BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LEAD MODEL 302

    MDR report key: 2862125 · Received December 7, 2012

    Report

    Report Number
    1644487-2012-03196
    Event Type
    Malfunction
    Date Received
    December 7, 2012
    Date of Event
    November 9, 2012
    Report Date
    November 9, 2012
    Manufacturer
    CYBERONICS, INC.
    Product Code
    LYJ
    PMA / PMN Number
    P970003
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    MANUFACTURER REVIEWED X-RAYS OF IMPLANTED DEVICE. X-RAYS REVIEWED BY THE MANUFACTURER, NO GROSS LEAD DISCONTINUITIES VISUALIZED. DEVICE FAILURE IS SUSPECTED BUT DID NOT CAUSE OR CONTRIBUTE TO A DEATH OR SERIOUS INJURY.

    Additional Manufacturer Narrative · 1

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

    Description of Event or Problem · 1

    A PHYSICIAN'S LETTER DATED (B)(6) 2012 WAS RECEIVED ON (B)(6) 2012. THE NOTE INDICATED THAT THE PATIENT WAS SEEN ON (B)(6) 2012. WHILE HIGH IMPEDANCE WAS NOTED, THE PATIENT HAD NOT HAD ANY CHANGE IN SEIZURE ACTIVITY. THE PATIENT WAS DOING VERY WELL AND HAD NOT HAD ANY SYMPTOMS THAT WOULD SUGGEST SUBCLINICAL SEIZURES OR NEUROLOGICAL PROBLEMS. A LEAD TEST ON THIS DATE INDICATED HIGH IMPEDANCE. THE PHYSICIAN WROTE THAT THE PATIENT LIKELY HAS MOISTURE ALONG THE LEAD AND THIS WAS CAUSING HIGH IMPEDANCE. THE PATIENT'S SETTINGS WERE ADJUSTED AND DID NOT PRODUCE A COUGH; THEREFORE, IT SUGGESTS THAT THE PATIENT WAS NOT RECEIVING ADEQUATE STIMULATION. BECAUSE THE PATIENT WAS STABLE CLINICALLY, THE DEVICE WOULD NOT BE REPLACED AT THIS TIME. SURGERY IS STILL LIKELY BUT HAS NOT OCCURRED. X-RAYS DATED (B)(6) 2012 WERE RECEIVED ON (B)(6) 2012 AND REVIEWED. THE GENERATOR IS VISIBLE IN THE LEFT CHEST. THE GENERATOR IS PLACED NORMALLY. THE CONNECTOR PIN APPEARS FULLY INSERTED INSIDE THE CONNECTOR BLOCK. THE FEEDTHRU WIRES APPEAR INTACT. LEAD WIRES APPEAR INTACT AT THE CONNECTOR PIN. LEAD IS PRESENT BEHIND THE GENERATOR. THERE ARE NO VISIBLE SHARP ANGLES OR GROSS DISCONTINUITIES. FROM ON THE X-RAY IMAGES SEEN, THERE IS NO OBVIOUS CAUSE FOR THE REPORTED HIGH IMPEDANCE ALLEGATION

    Description of Event or Problem · 1

    ON (B)(6) 2012, IT WAS REPORTED THAT DIAGNOSTICS ON THIS PATIENT'S GENERATOR INDICATED HIGH IMPEDANCE (10000 OHMS) AND THAT STIMULATION WAS NOT BEING DELIVERED. NOTES INDICATED THAT THIS PATIENT'S DEVICE WAS LAST INTERROGATED IN (B)(6) 2012 WITH NORMAL RESULTS. THE PATIENT DID NOT HAVE ANY TRAUMA, NECK MANIPULATIONS, OR OTHER EVENTS. THREE PROGRAMMING SYSTEMS WERE USED WITH THE SAME HIGH IMPEDANCE RESULTS. CLINIC NOTES INDICATED DATED (B)(6) 2012 INDICATE THAT THE PATIENT DID NOT HAVE ANY CONFUSIONAL STATES THAT WERE CONCERNING FOR HIS SEIZURES, EXCEPT FOR IN 2009 WHEN HE HAD AN ISOLATED EPISODE FOR A MINUTE DURATION. THE PATIENT'S DEVICE WAS LAST INTERROGATED IN (B)(6) 2012, AND IT APPEARED OKAY IN THE NOTE. THE PATIENT'S DEVICE WAS INTERROGATED, HIGH IMPEDANCE WAS NOTED, AND THE DEVICE WAS PROGRAMMED OFF. THE PHYSICIAN INDICATED THAT THE HIGH IMPEDANCE MAY BE THE RESULT OF SCAR TISSUE ON (B)(6) 2012, THE PATIENT'S DEVICE WAS PROGRAMMED BACK ON TO VERY LOW SETTINGS. THE DEVICE WAS PROGRAMMED TO VERY LOW SETTINGS. SURGERY IS LIKELY BUT HAS NOT TAKEN PLACE. X-RAYS WERE TAKEN AND SUBMITTED FOR REVIEW; HOWEVER, THE IMAGES COULD NOT BE ACCESSED.

    Description of Event or Problem · 1

    THE PATIENT UNDERWENT GENERATOR AND LEAD REPLACEMENT SURGERY ON (B)(6) 2015. PRE-SURGICAL DEVICE DIAGNOSTICS INDICATED HIGH LEAD IMPEDANCE AND THE BATTERY WAS NOT AT END OF SERVICE. INTRA-OPERATIVE TESTING OF THE CONNECTION OF THE LEAD TO THE PULSE GENERATOR REVEALED NO ANOMALIES. THE SURGEON DID NOT OBSERVE ANY VISIBLE BREAKS OR KINKS IN THE LEAD. A SUBSEQUENTLY RECEIVED IMPLANT CARD INDICATED LEAD DISCONTINUITY AT THE REASON FOR DEVICE REPLACEMENT. THE EXPLANTED GENERATOR AND LEAD HAVE BEEN RETURNED TO THE MANUFACTURER AND ARE CURRENTLY UNDERGOING PRODUCT ANALYSIS.

    Description of Event or Problem · 1

    PRODUCT ANALYSIS OF THE RETURNED LEAD CONFIRMED A DISCONTINUITY OF BOTH QUADRIFILAR COILS. EXTENSIVE PITTING AND MECHANICAL DAMAGE WAS IDENTIFIED AT THE COIL BREAK LOCATIONS WHICH PREVENTED DETERMINATION OF THE COIL FRACTURE TYPE. EVIDENCE OF STRESS INDUCED FRACTURE (FROM ROTATIONAL FORCES) WAS OBSERVED ON ONE OF THE BROKEN COIL STRANDS. WITH THE EXCEPTION OF THE OBSERVED DISCONTINUITIES THE CONDITION OF THE RETURNED LEAD PORTIONS IS CONSISTENT WITH CONDITIONS THAT TYPICALLY EXIST FOLLOWING AN EXPLANT PROCEDURE. NO OTHER OBVIOUS ANOMALIES WERE NOTED. NOTE THAT THE ANCHOR TETHER AND (+) WHITE ELECTRODE WERE NOT RETURNED FOR ANALYSIS; THEREFORE A COMPLETE EVALUATION COULD NOT BE PERFORMED ON THE ENTIRE LEAD PRODUCT. NO ANOMALIES WERE DETECTED DURING ANALYSIS OF THE RETURNED PULSE GENERATOR AND THE GENERATOR HAD NOT REACHED AN END OF SERVICE BATTERY CONDITION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 LEAD MODEL 302 LEAD LYJ CYBERONICS, INC. 302-30 200931

    Patients

    Seq Age Sex Outcome Treatment
    1 18 YR