Overai 10.2.e. tenzij sander?"- aangegeven. Doc. 223 Report Form Manufacturer's Incident Report i "Nari Medical Devices Vigilance System import XML I Iirx save-I? ?ll with test data Follow Up I ?ll with test data Final I I new case, keep base data I Version 2.26en 2012-12-04 I 1 administrative information Recipient (Name of NCA) Stamp box Dutch Healthcare Inspectorate Address of National Competent Ruilority St. 16 NL-351 1 BS Utrecht Date of this report . 1 Reference number assigned by the manufacturer Reference number assigned by NCA m-rl -r Type of report Initial report f? Follow-up report Combined initial and final report Final report Does the incident represent a serious public health threat? yes 5 no Classi?cation of incident Death i" Unanticipated Serious Deterioration in State of Health (3 All other reportable incidents Identify to what other NCA's this report was also sent United States FDA lit-formation on submitterof the report Status of submitter Manufacturer Authorised Representative within EEA and Switzerland and Turkey Others: (identify the role) 3MImff3WminfDWI??n Name Cyberonics Inc. Contact Home Address 100 Cyberonics Boulevard Postcode City 77058 Housman Phone Fax +1 {366} E-mail Country US - USA '34?'31 new Name Contact Name Address Postcode City Phone Fax E-mall Country AT - Austria ll WW 2:?1?31912. Idr?dM'V? -.- I new Name Cyberonlcs Inc. Contact Name Address 100 Cyberonlcs Boulevard Postcode City 77058 Houston Phone Fax +1 (sea)- E-mall Country US - USA It} Medical'devlteinformatien lass AIMD Active implants 1 WE MDD Class IVD Annex II List A (7 MDD Class f? IVD Annex II List (T MDD Class Ila IVD Devices for self-testing MDD Class I IVD General Nomenclature system (preferable GMDN) Nomenclature code GMDN 4404i Nomenclature text Vagus nerve electrical stimulation system lead Commercial name! brand name I make Lead Model Unknown Model number Catalogue number Unknown NA Serial numberls) (If applicable) Lotlbatch numberis) (if applicable) Unknown Unknown Software version number [if applicable) NA Device Date Expiry date Implant date (For Implants only) Explant date (For Implants only) Unknown Duration of Implantation (For Implants only. To be ?lled if the exact Implant and explant dates are unknown) Accessories I associated devices (if applicable) Generator Model 102 SN . Generator Model 103 SN Noti?ed Body (NB) lD-number 0344 lzfmiiahitaLtduiimiq-r . Date the incident occurred Incident description narrative User facility report reference number, If applicable 24 lid 4 25 lid 3 10.1.d 10.2.d 10.2.9 Manufacturer?s awareness date m! Number of patients involved (if knowu) 1 Number of medical devices involved (if known) 1. The lead was reportedly discarded after surgery. Medical device current (If known) Operator of the medical device at the time of incident [select one} Healthcare Professional (3 Patient f? Other uoc.22 Usa ye at the medical device iseiectfrom list below) initial use reuse of a single use medical device f" reuse of a reusable medical device re-serviced/refurbished . other problem noted prior use Patient but om! . . The patientEE 2' - g? 44*; 24 4 25 Md 3 +10id+102d +102g Remedial action taken by the healthcare facility relevant to the care of the patient The healthcare facility opted to replace the patient's lead to resolve the high impedance. Age of the patient at the time of incident, if applicable Years (7 months days Weight in kilograms, if applicable 9irjleieemaemymiamuon Fax Country NL - Netherlands 1'0 oomntents'ilnitiallFoliowmp report] ?oc 22 *5 Manufacturer's preliminary analysis Initial corrective actions implemented by the manufacturer Expected date of next report :12! Mint- of mint-femur: (creamer. ?5 . The manufacturer?s device analysis results The device was not returned to the manufacturer so an analysis could not be performed. Remedial actionlcorrective actionlpreventive action I Field Safety Corrective Action Time schedule for the implementation of the Identified actions - . he lead was discarded after explant, so was unable to be analyzed by the manufacturer. Further investigations is the manufacturer aware of similar incidents with this type of medical device with a similar root cause? (3 Yes No Number of similar incidents 76 If yes, state in which countries and the report reference numbers of the incidents. Austria (AT) - 1 Belgium (BE) - 4 Czech Republic (CZ) -1 France (FR) - 7 Germany (DE) 5 Greece - 1 Ireland (IE10.1.d 10.2.d 102.9 Israel {iL} -4 "flat. Italy (IT) - 4 Norway (NO) - 2 Saudi Arabia (SA) - 2 Spain (ES) - 5 Sweden (SE) - 12 The Netherlands (NL) - 6 Turkey (TR) - 6 Great Britain - 15 For ?nal reports only. The medical device has bean distributed to the following countries: within the EEA and Switzerland and Turkey .Candidate Countries HR EEA, candidate countries and Switzerland and Turkey Others: [a onetime Submission of this report does not, in itself, represent a nonoiusion by the manufacturer and?or authorised representative or the Nations! Competent Authority that the content or this report is oompiete or accurate; that the medioet deviants) listed taiied in any manner endior that the medtoat devisets) caused or contributed to the aiteged death or deterioration in the state at the heaith of any person. Signature print check send KM L-data by EeMall I af?rm that the information glven above ls correct to the best of my knowledge