BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BIPOL LEAD MODEL 300

    MDR report key: 2962475 · Received February 14, 2013

    Report

    Report Number
    1644487-2013-00409
    Event Type
    Malfunction
    Date Received
    February 14, 2013
    Date of Event
    January 16, 2013
    Report Date
    January 16, 2013
    Manufacturer
    CYBERONICS, INC.
    Product Code
    LYJ
    PMA / PMN Number
    P970003
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SC, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE FAILURE IS SUSPECTED, BUT DID NOT CAUSE OR CONTRIBUTE TO A DEATH OR SERIOUS INJURY.

    Additional Manufacturer Narrative · 1

    ONLY A PORTION OF THE LEAD WAS RETURNED FOR ANALYSIS WHICH DID NOT REVEAL ANY ANOMALIES. DEVICE FAILURE IS SUSPECTED IN TEH LEAD PORTION NOT RETURNED, BUT DID NOT CAUSE OR CONTRIBUTE TO A DEATH OR SERIOUS INJURY.

    Description of Event or Problem · 1

    THE TWO EXPLANTED GENERATORS AND LEAD WERE RECEIVED FOR PA. ANALYSIS OF THE EXPLANTED GENERATOR AND GENERATOR NOT USED REVEALED NO ANOMALIES FOUND WITH THE PULSE GENERATOR. AN ANALYSIS WAS ALSO PERFORMED ON THE RETURNED LEAD PORTIONS AND THE REPORTED LEAD FRACTURE WAS NOT CONFIRMED. THE REPORT INDICATED THAT DURING REVISION SURGERY THE SURGEON NOTICED SCAR TISSUE WRAPPED AROUND THE LEAD. WHILE REMOVING THE SCAR TISSUE, THE SURGEON REPORTED THAT HE ACTUALLY CUT THE LEAD. THE RETURNED LEAD ASSEMBLY WAS RECEIVED IN TWO PORTIONS, WHICH APPEARED TO HAVE BEEN CUT IN HALF. THE ABRADED OPENINGS FOUND ON THE OUTER SILICONE TUBING, MOST LIKELY PROVIDED THE LEAKAGE PATH FOR WHAT APPEARED TO BE REMNANTS OF DRIED BODY FLUIDS FOUND INSIDE THE OUTER SILICONE TUBING. FOR THE OBSERVED INNER TUBING FLUID REMNANTS, THERE WAS NO OBVIOUS PATH FOR FLUID INGRESS OTHER THAN THE CUT ENDS THAT WERE MADE DURING THE EXPLANTED PROCESS. THE CONDITION OF THE RETURNED LEAD PORTIONS IS CONSISTENT WITH CONDITIONS THAT TYPICALLY EXIST FOLLOWING AN EXPLANT PROCEDURE. NO OBVIOUS ANOMALIES WERE NOTED. THE SETSCREW MARKS FOUND ON THE LEAD CONNECTOR PINS PROVIDE EVIDENCE THAT, AT ONE POINT IN TIME, A GOOD MECHANICAL AND ELECTRICAL CONNECTION WAS PRESENT. CONTINUITY CHECKS OF THE RETURNED LEAD PORTIONS WERE PERFORMED, DURING THE VISUAL ANALYSIS, AND NO DISCONTINUITIES WERE IDENTIFIED. BASED ON THE FINDINGS IN THE PRODUCT ANALYSIS LAB, THERE IS NO EVIDENCE TO SUGGEST A DISCONTINUITY IN THE RETURNED PORTIONS OF THE DEVICE WHICH MAY HAVE CONTRIBUTED TO THE STATED ALLEGATIONS OF LEAD FRACTURE WITH THE EXCEPTION OF THE ACCIDENTAL CUT MADE BY THE SURGEON. IT WAS REPORTEDLY UNCLEAR WHY THE PATIENT HAD 'BAD SCARRING' AROUND THE LEAD. THE COMPANY REPRESENTATIVE PRESENT AT SURGERY CONFIRMED THAT THE LEAD APPEARED TO HAVE A FULL BREAK.

    Description of Event or Problem · 1

    THE PATIENT WAS REFERRED FOR PROPHYLACTIC GENERATOR REPLACEMENT ON (B)(6) 2013. ON (B)(6) 2013, IT WAS REPORTED THAT THE PATIENT HAD GENERATOR AND LEAD REPLACEMENT ON (B)(6) 2013 DUE TO THE SURGEON FINDING THE LEAD APPEARING 'FRAYED' AFTER DISCONNECTING THE GENERATOR FROM THE LEAD. IT WAS CONFIRMED THAT ALL DIAGNOSTICS IN THE OFFICE SETTING WERE WITHIN NORMAL LIMITS PRIOR TO SURGERY. NO DIAGNOSTICS WERE PERFORMED PRIOR TO SURGERY SINCE DIAGNOSTICS WERE PERFORMED BY THE NEUROLOGIST'S OFFICE THE WEEK PRIOR. DURING SURGERY, THE SURGEON NOTICED SCAR TISSUE WRAPPED AROUND THE LEAD. SURGEON SAID HE WAS GOING TO CLEAN UP SCAR TISSUE AROUND THE LEAD. AFTER THE SURGEON MENTIONED IT LOOKED LIKE SCAR TISSUE, HE DISCONNECTED THE LEAD, AND THEN SAID 'LEAD LOOKS BROKEN;' THEN, THE SURGEON REPORTED THAT HE ACTUALLY CUT THE LEAD. IT WAS CLARIFIED THAT HE SAID THE LEAD LOOKED BROKEN EVEN MORE HE ACTUALLY CUT THE LEAD. IT IS UNCLEAR WHY THE PATIENT HAD 'BAD SCARRING' AROUND THE LEAD. THE DEVICE WAS TURNED ON AFTER SURGERY, AND THE PATIENT IS RECOVERING WELL. NO X-RAYS WERE TAKEN SINCE NO LEAD ISSUE WAS SUSPECTED PRIOR TO SURGERY. THE REPLACEMENT GENERATOR WAS ALSO EXPLANTED DUE TO COMPATIBILITY WITH THE NEW LEAD. THE TWO EXPLANTED GENERATORS AND LEAD WERE RECEIVED BY THE MANUFACTURER ON (B)(4) 2013 FOR PRODUCT ANALYSIS. HOWEVER, ANALYSIS HAS NOT BEEN COMPLETED TO DATE. PREVIOUSLY, IT WAS REPORTED FROM THE NEUROLOGIST'S OFFICE THAT THE PATIENT WAS EVALUATED FOR THE FIRST TIME ON (B)(6) 2012, AND PER THE PATIENT'S MOTHER, THE PATIENT HAD GOOD SEIZURE CONTROL AT ONE POINT, BUT WAS NOW EXPERIENCING SEIZURES EVERY DAY (BELOW PRE-VNS SEIZURE FREQUENCY). THE MOTHER BELIEVED THAT THE INCREASED SEIZURES MUST HAVE BEEN DUE TO THE VNS BATTERY, SINCE THE PATIENT WAS DOING FINE BEFORE. THERE WERE NO OTHER CONTRIBUTING FACTORS, AND NO MEDICATION CHANGES THAT COULD HAVE CONTRIBUTED TO THIS INCREASE. THE PATIENT WAS REFERRED FOR PROPHYLACTIC GENERATOR REPLACEMENT SINCE THE MOTHER WAS INSISTENT THAT THE SEIZURES WERE DUE TO THE BATTERY. THE NEUROLOGIST REPORTEDLY DID NOT KNOW THE CAUSE OF THE INCREASED SEIZURES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    65407 BIPOL LEAD MODEL 300 LEAD LYJ CYBERONICS, INC. 300-20 28125C

    Patients

    Seq Age Sex Outcome Treatment
    1 20 YR