BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PRECISION®

    MDR report key: 4152968 · Received October 8, 2014

    Report

    Report Number
    3006630150-2014-02295
    Event Type
    Malfunction
    Date Received
    October 8, 2014
    Date of Event
    September 15, 2014
    Report Date
    September 15, 2014
    Manufacturer
    BOSTON SCIENTIFIC NEUROMODULATION
    Product Code
    LGW
    PMA / PMN Number
    030017
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    SC-1110-02/(B)(4) DEVICE EVALUATION INDICATED THAT THE IPG PASSED VISUAL, ELECTRICAL, PERFORMANCE AND PHOTOGRAPHIC IMAGING TESTS PERFORMED. THE COMPLAINT REGARDING CHARGING ISSUE WAS NOT VERIFIED. IN THE LAB, A TEST CHARGER WAS ABLE TO COUPLE WITH THE IPG WITHOUT ANY ISSUE. THE IPG WAS SUCCESSFULLY CHARGED TO FULL CAPACITY. THIS RESULT ATTESTED THAT THE DEVICE IS CAPABLE OF BEING CHARGED FULLY UNDER A PROPER CHARGING METHOD. BATTERY DEPLETION WAS WITHIN THE NORMAL RANGE. THE DEVICE PASSED ALL REQUIRED TESTS AND REVEALED NORMAL DEVICE CHARACTERISTICS.

    Additional Manufacturer Narrative · 1

    (B)(4).

    Additional Manufacturer Narrative · 1

    ADDITIONAL INFORMATION WAS RECEIVED THAT THE PATIENT UNDERWENT A REVISION PROCEDURE WHEREIN THE IPG WAS REPLACED. THE PHYSICIAN SUSPECTED DEVICE MALFUNCTION. THE PATIENT WAS DOING WELL POSTOPERATIVELY.

    Description of Event or Problem · 1

    A REPORT WAS RECEIVED THAT PATIENT'S CHARGER WAS NOT COUPLING WITH THE IPG APPROPRIATELY CAUSING THE PATIENT DIFFICULTY CHARGING. PATIENT WILL UNDERGO AN IPG REVISION.

    Description of Event or Problem · 1

    A REPORT WAS RECEIVED THAT PATIENT'S CHARGER WAS NOT COUPLING WITH THE IPG APPROPRIATELY CAUSING THE PATIENT DIFFICULTY CHARGING. PATIENT WILL UNDERGO AN IPG REVISION.

    Description of Event or Problem · 1

    A REPORT WAS RECEIVED THAT PATIENT'S CHARGER WAS NOT COUPLING WITH THE IPG APPROPRIATELY CAUSING THE PATIENT DIFFICULTY CHARGING. PATIENT WILL UNDERGO AN IPG REVISION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    631835 PRECISION® SPINAL CORD STIMULATOR LGW BOSTON SCIENTIFIC NEUROMODULATION SC-1110-02 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 67 YR Required Intervention