BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PRECISION®

    MDR report key: 2930536 · Received January 28, 2013

    Report

    Report Number
    3006630150-2013-00153
    Event Type
    Injury
    Date Received
    January 28, 2013
    Date of Event
    January 10, 2013
    Report Date
    January 10, 2013
    Manufacturer
    BOSTON SCIENTIFIC NEUROMODULATION
    Product Code
    LGW
    PMA / PMN Number
    030017
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    ADDITIONAL INFORMATION WAS RECEIVED THAT THE PATIENT DID WELL POSTOPERATIVELY, AND THE PAIN AT THE POCKET SITE WAS RESOLVED. DEVICE EVALUATION INDICATED THAT THE IPG PASSED THE VISUAL AND ELECTRICAL TESTS PERFORMED. THE POSSIBILITY THAT ELECTRICAL LEAKAGE COULD CAUSE PAIN AT THE PATIENT'S POCKET SITE WAS INVESTIGATED. THE DEVICE OUTPUT WAS MONITORED FOR EXCESSIVE LEAKAGE CURRENT OR SPURIOUS SIGNALS IN A SALINE SOLUTION WHILE PROGRAMMED TO THE PATIENT'S LATEST SETTING. LEAKAGE CURRENT WAS IN THE NORMAL RANGE. THEREFORE, THE REPORTED COMPLAINT OF THE IPG CAUSING PAIN AT THE POCKET SITE WAS NOT DUPLICATED OR CONFIRMED. DURING TESTING, IT WAS DETERMINED THAT THE ANALOG INTEGRATED CIRCUIT HAD DAMAGE TO THE MULTIPLEXER LOCATED IN THE SECTION THAT CALCULATED THE IMPEDANCE. THIS DAMAGE WAS UNRELATED TO THE COMPLAINT AS IT CAUSED THE IMPEDANCE READINGS TO REGISTER AS LOW IMPEDANCE INSTEAD OF HIGH ON OPEN CHANNELS AND ONLY SLIGHTLY LOWER THAN NORMAL ON CHANNELS CONNECTED TO A LOAD. THIS WAS THE REASON THE IPG FAILED. IT WAS REPORTED THAT ELECTROCAUTERY WAS USED DURING THE EXPLANT PROCEDURE.

    Description of Event or Problem · 1

    A REPORT WAS RECEIVED THAT THE PATIENT UNDERWENT AN EXPLANT PROCEDURE WHEREIN THE IPG WAS EXPLANTED DUE TO PAIN AT THE IPG SITE AND THE LEADS REMAINED IMPLANTED. THE PATIENT EXPERIENCED CONSTANT PAIN WITH ANY PRESSURE AROUND THE IPG SITE AND WAS UNABLE TO LIE ON HIS BACK.

    Description of Event or Problem · 1

    A REPORT WAS RECEIVED THAT THE PATIENT UNDERWENT AN EXPLANT PROCEDURE WHEREIN THE IPG WAS EXPLANTED DUE TO PAIN AT THE IPG SITE AND THE LEADS REMAINED IMPLANTED. THE PATIENT EXPERIENCED CONSTANT PAIN WITH ANY PRESSURE AROUND THE IPG SITE AND WAS UNABLE TO LIE ON HIS BACK.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    36608 PRECISION® SPINAL CORD STIMULATOR LGW BOSTON SCIENTIFIC NEUROMODULATION SC-1110-02 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 70 YR Required Intervention