BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PRECISION®

    MDR report key: 3130958 · Received May 24, 2013

    Report

    Report Number
    3006630150-2013-01037
    Event Type
    Malfunction
    Date Received
    May 24, 2013
    Date of Event
    April 30, 2013
    Report Date
    April 30, 2013
    Manufacturer
    BOSTON SCIENTIFIC NEUROMODULATION
    Product Code
    LGW
    PMA / PMN Number
    030017
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    ADDITIONAL INFORMATION WAS RECEIVED THAT ONLY ONE CONTACT WAS TURNED A BIT ON ONE SIDE AND ALL CONTACTS WERE REMOVED. THE COMPLAINT HAS BEEN CONFIRMED. VISUAL INSPECTION FOUND THAT ELECTRODE # 3 IS PARTIALLY DISLODGED FROM THE PADDLE. THE ELECTRODE IS STILL CONNECTED TO ITS CORRESPONDING CABLE. THE ROOT CAUSE OF DISLODGED ELECTRODE IS UNKNOWN. VISUAL INSPECTION ALSO REVEALED THAT THE LEAD WAS CLEANLY CUT 7 INCHES FROM PADDLE END OF LEAD. THE CLEAN CUT DAMAGE IS A RESULT OF A TYPICAL EXPLANT PROCEDURE AND IT IS NOT CONSIDERED A FAILURE. TWO OF THE PROXIMAL ENDS OF THE PADDLE LEAD WERE NOT RETURNED.

    Description of Event or Problem · 1

    A REPORT WAS RECEIVED THAT DURING THE PATIENT'S REVISION PROCEDURE, THE PHYSICIAN NOTICED THAT A CONTACT WAS LOOSE FROM THE PADDLE LEAD. THE PADDLE LEAD WAS REPLACED, AND THE PATIENT DID WELL POSTOPERATIVELY.

    Description of Event or Problem · 1

    A REPORT WAS RECEIVED THAT DURING THE PATIENT'S REVISION PROCEDURE, THE PHYSICIAN NOTICED THAT A CONTACT WAS LOOSE FROM THE PADDLE LEAD. THE PADDLE LEAD WAS REPLACED, AND THE PATIENT DID WELL POSTOPERATIVELY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    231586 PRECISION® SPINAL CORD STIMULATOR LGW BOSTON SCIENTIFIC NEUROMODULATION SC-8216-70 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 56 YR