BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PRECISION®

    MDR report key: 2010972 · Received March 8, 2011

    Report

    Report Number
    3006630150-2011-00280
    Event Type
    Injury
    Date Received
    March 8, 2011
    Date of Event
    February 1, 2011
    Report Date
    February 1, 2011
    Manufacturer
    BOSTON SCIENTIFIC NEUROMODULATION
    Product Code
    LGW
    PMA / PMN Number
    030017
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SC, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    ADDITIONAL INFORMATION STATED THAT THE PHYSICIAN EXPLANTED THE OLD IPG AND RE-IMPLANTED THE PATIENT WITH A NEW IPG. THE PATIENT IS REPORTEDLY DOING WELL FOLLOWING THE PROCEDURE. THE IPG PASSED VISUAL, ELECTRICAL, PHOTOGRAPHIC IMAGING AND PERFORMANCE TESTS PERFORMED. THE COMPLAINT OF THE DIFFICULTY CHARGING THE IPG WAS NOT CONFIRMED. THE IPG EXHIBITS NORMAL CHARGING AND DISCHARGING CHARACTERISTICS WHEN CHARGED WITH RECOMMENDED OPTIMAL ALIGNMENT. THE BATTERY IS DEPLETING ITS CHARGE AT A RATE THAT IS TYPICAL IPG BATTERY DEPLETION RATE. THE SPECIFIC REASON FOR THE LOW CHARGING CURRENT IS UNKNOWN BUT THIS CONDITION CAN OCCUR IF THE IPG IS FLIPPED, TILTED, OR DEEP INSIDE THE POCKET.

    Description of Event or Problem · 1

    A REPORT WAS RECEIVED THAT THE PATIENT WAS HAVING DIFFICULTY CHARGING HIS IPG. AFTER SEVERAL ATTEMPTS AT TROUBLESHOOTING IT WAS DETERMINED THAT THE IPG POCKET IS TOO DEEP. A POCKET REVISION HAS BEEN RECOMMENDED.

    Description of Event or Problem · 1

    A REPORT WAS RECEIVED THAT THE PATIENT WAS HAVING DIFFICULTY CHARGING HIS IPG. AFTER SEVERAL ATTEMPTS AT TROUBLESHOOTING IT WAS DETERMINED THAT THE IPG POCKET IS TOO DEEP. A POCKET REVISION HAS BEEN RECOMMENDED.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 50 YR Required Intervention