BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PRECISION®

    MDR report key: 3003060 · Received March 13, 2013

    Report

    Report Number
    3006630150-2013-00442
    Event Type
    Injury
    Date Received
    March 13, 2013
    Date of Event
    February 14, 2013
    Report Date
    February 18, 2013
    Manufacturer
    BOSTON SCIENTIFIC NEUROMODULATION
    Product Code
    LGW
    PMA / PMN Number
    030017
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AZ, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    ADDITIONAL INFORMATION WAS RECEIVED THAT THE PATIENT UNDERWENT BATTERY REPLACEMENT AND WAS DOING WELL FOLLOWING THE PROCEDURE.

    Additional Manufacturer Narrative · 1

    DEVICE EVALUATION INDICATED THAT THE IPG PASSED VISUAL, ELECTRICAL, PERFORMANCE AND PHOTOGRAPHIC IMAGING TESTS PERFORMED. THE COMPLAINT REGARDING POCKET PAIN AND DIFFICULTY CHARGING THE IPG WAS NOT VERIFIED. THE DEVICE PASSED ALL THE REQUIRED TESTS. THE DEVICE EXHIBITED NORMAL DEVICE CHARACTERISTICS.

    Description of Event or Problem · 1

    A REPORT WAS RECEIVED THAT THE PATIENT HAD DIFFICULTY CHARGING HER IPG AND HAD PAIN AT THE BATTERY SITE. THE PATIENT WILL UNDERGO A POCKET REVISION.

    Description of Event or Problem · 1

    A REPORT WAS RECEIVED THAT THE PATIENT HAD DIFFICULTY CHARGING HER IPG AND HAD PAIN AT THE BATTERY SITE. THE PATIENT WILL UNDERGO A POCKET REVISION.

    Description of Event or Problem · 1

    A REPORT WAS RECEIVED THAT THE PATIENT HAD DIFFICULTY CHARGING HER IPG AND HAD PAIN AT THE BATTERY SITE. THE PATIENT WILL UNDERGO A POCKET REVISION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    106144 PRECISION® SPINAL CORD STIMULATOR LGW BOSTON SCIENTIFIC NEUROMODULATION SC-1110-02 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 56 YR Required Intervention