BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PRECISION®

    MDR report key: 6224153 · Received January 4, 2017

    Report

    Report Number
    3006630150-2016-03975
    Event Type
    Malfunction
    Date Received
    January 4, 2017
    Date of Event
    December 27, 2016
    Report Date
    December 27, 2016
    Manufacturer
    BOSTON SCIENTIFIC NEUROMODULATION
    Product Code
    LGW
    PMA / PMN Number
    030017
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SC, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    ADDITIONAL SUSPECT MEDICAL DEVICE COMPONENT INVOLVED IN THE EVENT: MODEL #: SC-1110-02, SERIAL #: (B)(4), DESCRIPTION: PRECISION IMPLANTABLE PULSE GENERATOR (IPG).

    Additional Manufacturer Narrative · 1

    THE RETURNED IPG(SC-1132/SN:(B)(4))WAS ANALYZED AND NO ANOMALIES WAS FOUND. SC-8120-70/SN:(B)(4): DEVICE EVALUATION INDICATED THAT THE COMPLAINT OF HIGH IMPEDANCE HAS BEEN CONFIRMED. X-RAY INSPECTION CONFIRMED ALL CABLES OF THE PADDLE LEAD TAILS WERE FRACTURED AT APPROXIMATELY 24 CM FROM PROXIMAL ENDS. THE FRACTURED CABLES RESULTED IN LOSS OF STIMULATION AND HIGH IMPEDANCES. THE REPORTED COMPLAINT STATES THAT PATIENT HAD A CAR ACCIDENT AND IT HAS NOT BEEN THE SAME SINCE. ADDITIONALLY, VISUAL INSPECTION REVEALED THAT PADDLE LEAD TAILS WERE CLEANLY CUT AND THE CABLES ARE EXPOSED. THE CLEAN CUT DAMAGE IS A RESULT OF A TYPICAL EXPLANT PROCEDURE AND IT IS NOT CONSIDERED A FAILURE.

    Additional Manufacturer Narrative · 1

    ADDITIONAL INFORMATION WAS RECEIVED THAT THERE WERE NO EXPOSED WIRES PRIOR TO THE REMOVAL OF THE LEAD BUT THERE WERE HIGH IMPEDANCES NOTED.

    Description of Event or Problem · 1

    A REPORT WAS RECEIVED THAT THE PATIENT WAS HAVING HIGH IMPEDANCES AND PAIN AREAS WERE NOT COVERED ANY LONGER. THE PATIENT UNDERWENT A REVISION PROCEDURE WHEREIN THE IPG AND LEAD WERE REPLACED. IT WAS NOTED THAT THERE WAS A BREAK IN THE LEAD ONCE IT WAS TAKEN OUT. THE PATIENT FURTHER STATED THAT IT HAD NOT BEEN THE SAME SINCE SHE HAD A CAR ACCIDENT. NO DEVICE MALFUNCTION WAS SUSPECTED. THE PATIENT WAS DOING WELL POSTOPERATIVELY.

    Description of Event or Problem · 1

    A REPORT WAS RECEIVED THAT THE PATIENT WAS HAVING HIGH IMPEDANCES AND PAIN AREAS WERE NOT COVERED ANY LONGER. THE PATIENT UNDERWENT A REVISION PROCEDURE WHEREIN THE IPG AND LEAD WERE REPLACED. IT WAS NOTED THAT THERE WAS A BREAK IN THE LEAD ONCE IT WAS TAKEN OUT. THE PATIENT FURTHER STATED THAT IT HAD NOT BEEN THE SAME SINCE SHE HAD A CAR ACCIDENT. NO DEVICE MALFUNCTION WAS SUSPECTED. THE PATIENT WAS DOING WELL POSTOPERATIVELY.

    Description of Event or Problem · 1

    A REPORT WAS RECEIVED THAT THE PATIENT WAS HAVING HIGH IMPEDANCES AND PAIN AREAS WERE NOT COVERED ANY LONGER. THE PATIENT UNDERWENT A REVISION PROCEDURE WHEREIN THE IPG AND LEAD WERE REPLACED. IT WAS NOTED THAT THERE WAS A BREAK IN THE LEAD ONCE IT WAS TAKEN OUT. THE PATIENT FURTHER STATED THAT IT HAD NOT BEEN THE SAME SINCE SHE HAD A CAR ACCIDENT. NO DEVICE MALFUNCTION WAS SUSPECTED. THE PATIENT WAS DOING WELL POSTOPERATIVELY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    5928 PRECISION® SPINAL CORD STIMULATOR LGW BOSTON SCIENTIFIC NEUROMODULATION SC-8120-70 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 58 YR