BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PULSE GEN MODEL 102

    MDR report key: 2191324 · Received July 27, 2011

    Report

    Report Number
    1644487-2011-01676
    Event Type
    Malfunction
    Date Received
    July 27, 2011
    Date of Event
    March 8, 2011
    Report Date
    June 29, 2011
    Manufacturer
    CYBERONICS, INC.
    Product Code
    LYJ
    PMA / PMN Number
    P970003
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Description of Event or Problem · 1

    IT WAS REPORTED BY A PHYSICIAN THAT THE PT HAD A SEIZURE AFTER HAVING BEEN SEIZURE FREE "FOR A LONG TIME". DIAGNOSTIC TESTING ON THIS DATE WAS PERFORMED, WHICH SHOWED PROPER DEVICE FUNCTION. THE PT SUBSEQUENTLY UNDERWENT FOR A PROPHYLACTIC REPLACEMENT. THE EXTENDED GENERATOR WAS RETURNED FOR ANALYSIS. A VISUAL ASSESSMENT ON THE FEED-THRU ASSEMBLY SHOWED POSSIBLE EXCESSIVE BENDS IN THE POSITIVE FEED-THRU WIRE. IN ADDITION, SEPARATION OF THE SILVER POLYIMIDE TO POSITIVE AND NEGATIVE FEED-THRU WIRE CONNECTIONS WAS OBSERVED. THE PULSE GENERATOR DIAGNOSTICS WERE AS EXPECTED FOR THE PROGRAMMED PARAMETERS. THE MOST PROBABLE ROOT CAUSE FOR THE ANOMALIES WAS IDENTIFIED TO BE AN OPEN CAPACITOR, FOR WHICH MANIPULATION OF THE FEED-THRU WIRES MAY HAVE BEEN A CONTRIBUTING FACTOR. A REVIEW OF THE MANUFACTURER'S DESIGN HISTORY FILES REVEALED NO ANOMALIES WITH THE DEVICE AT DISTRIBUTION. ATTEMPTS FOR FURTHER INFO HAVE BEEN UNSUCCESSFUL TO DATE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PULSE GEN MODEL 102 LYJ CYBERONICS, INC. 102 010657

    Patients

    Seq Age Sex Outcome Treatment
    1 22 YR