BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PRECISION®

    MDR report key: 2012493 · Received March 9, 2011

    Report

    Report Number
    3006630150-2011-00353
    Event Type
    Injury
    Date Received
    March 9, 2011
    Date of Event
    January 14, 2011
    Report Date
    February 18, 2011
    Manufacturer
    BOSTON SCIENTIFIC NEUROMODULATION
    Product Code
    LGW
    PMA / PMN Number
    030017
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MD, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THE IPG PASSED VISUAL, ELECTRICAL, PHOTOGRAPHIC IMAGING AND PERFORMANCE TESTS PERFORMED. THE COMPLAINT OF DIFFICULTY CHARGING WAS NOT CONFIRMED. BATTERY PROFILE REVEALED A MAXIMUM DEPLETION RATE PER DAY, WHICH IS WITHIN THE EXPECTED RANGE. DEVICE EXHIBITS NORMAL CHARGING AND DISCHARGING CHARACTERISTICS.

    Description of Event or Problem · 1

    A REPORT WAS RECEIVED THAT A PATIENT WAS NOT ABLE TO CHARGE HIS IPG. AFTER UNSUCCESSFUL ATTEMPTS AT TROUBLESHOOTING WERE PERFORMED, THE PHYSICIAN CHOSE TO REPLACE THE IPG. THE PATIENT IS REPORTEDLY DOING WELL FOLLOWING THE PROCEDURE.

    Description of Event or Problem · 1

    A REPORT WAS RECEIVED THAT A PATIENT WAS NOT ABLE TO CHARGE HIS IPG. AFTER UNSUCCESSFUL ATTEMPTS AT TROUBLESHOOTING WERE PERFORMED, THE PHYSICIAN CHOSE TO REPLACE THE IPG. THE PATIENT IS REPORTEDLY DOING WELL FOLLOWING THE PROCEDURE.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 62 YR Required Intervention