BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PRECISION®

    MDR report key: 3841907 · Received May 30, 2014

    Report

    Report Number
    3006630150-2014-01255
    Event Type
    Malfunction
    Date Received
    May 30, 2014
    Date of Event
    April 29, 2014
    Report Date
    May 7, 2014
    Manufacturer
    BOSTON SCIENTIFIC NEUROMODULATION
    Product Code
    LGW
    PMA / PMN Number
    030017
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CO, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    ADDITIONAL INFORMATION WAS RECEIVED THAT THE PATIENT UNDERWENT A REVISION PROCEDURE WHEREIN THE IPG WAS REPLACED. THERE WAS A POSSIBLE PROBLEM WITH THE IPG SINCE THE PATIENT HAD AN MRI WHILE THE SYSTEM WAS STILL IMPLANTED.

    Additional Manufacturer Narrative · 1

    SC-1110 (SN (B)(4)) DEVICE EVALUATION INDICATED THAT THE IPG PASSED VISUAL, ELECTRICAL, PERFORMANCE AND PHOTOGRAPHIC IMAGING TESTS PERFORMED. THE POSSIBILITY THAT ELECTRICAL LEAKAGE COULD CAUSE URINARY INCONTINENCE AND POCKET PAIN AFTER IPG MIGRATION IN THE POCKET WAS INVESTIGATED. THE DEVICE OUTPUT WAS MONITORED FOR EXCESSIVE LEAKAGE CURRENT OR SPURIOUS SIGNALS IN A SALINE SOLUTION, WHILE PROGRAMMED TO THE PATIENT¿S LATEST SETTING. LEAKAGE CURRENT WAS IN THE NORMAL RANGE. THEREFORE, THE REPORTED COMPLAINT OF THE IPG CAUSING PAIN AT THE POCKET SITE OR URINARY INCONTINENCE WAS NOT DUPLICATED OR CONFIRMED. DEVICE EXHIBITS NORMAL DEVICE CHARACTERISTICS.

    Description of Event or Problem · 1

    A REPORT WAS RECEIVED THAT THE PATIENT¿S IPG WAS NON-FUNCTIONAL. THE PATIENT WILL UNDERGO AN IPG REPLACEMENT PROCEDURE.

    Description of Event or Problem · 1

    A REPORT WAS RECEIVED THAT THE PATIENT¿S IPG WAS NON-FUNCTIONAL. THE PATIENT WILL UNDERGO AN IPG REPLACEMENT PROCEDURE.

    Description of Event or Problem · 1

    A REPORT WAS RECEIVED THAT THE PATIENT¿S IPG WAS NON-FUNCTIONAL. THE PATIENT WILL UNDERGO AN IPG REPLACEMENT PROCEDURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    319431 PRECISION® SPINAL CORD STIMULATOR LGW BOSTON SCIENTIFIC NEUROMODULATION SC-1110 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 50 YR