BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PRECISION

    MDR report key: 2950729 · Received February 8, 2013

    Report

    Report Number
    3006630150-2013-00188
    Event Type
    Injury
    Date Received
    February 8, 2013
    Date of Event
    November 22, 2012
    Report Date
    December 5, 2012
    Manufacturer
    BOSTON SCIENTIFIC NEUROMODULATION
    Product Code
    LGW
    PMA / PMN Number
    030017
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    ADDITIONAL INFORMATION WAS RECEIVED THAT THE PATIENT'S IPG WAS EXPLANTED AS IT WAS PLACED TOO DEEP IN THE POCKET SITE. THE PATIENT IS OBESE AND HAD DIFFICULTY CHARGING THE IPG DUE TO IT'S LOCATION. MALFUNCTION WAS NOT SUSPECTED WITH THE IPG. THE PATIENT WAS IMPLANTED WITH A NEW IPG AND IS REPORTEDLY DOING WELL.

    Additional Manufacturer Narrative · 1

    THE RETURNED PRODUCT INVESTIGATION INDICATED THAT THE IPG PASSED ELECTRICAL, PERFORMANCE, PHOTOGRAPHIC AND VISUAL INSPECTION TESTS. THE DEVICE EXHIBITS NORMAL CHARGING AND DISCHARGING CHARACTERISTICS WHEN CHARGED WITH RECOMMENDED OPTIMAL ALIGNMENT. THE IPG IS DEPLETING AT A TYPICAL BATTERY DEPLETION RATE WITH THE STIMULATION TURNED ON. THE PATIENT IS OBESE, AND THE DEVICE WAS NOT ABLE TO CHARGE DUE TO ITS DEEP POCKET LOCATION.

    Description of Event or Problem · 1

    A REPORT WAS RECEIVED THAT A PATIENT WILL UNDERGO A POCKET REVISION AND IPG REPLACEMENT DUE TO DIFFICULTY CHARGING. THE PATIENT HAS EXPERIENCED DIFFICULTY CHARGING SINCE BEING IMPLANTED. WHEN THE CHARGER IS PLACED OVER THE POCKET SITE THE CHARGER CONTINUOUSLY BEEPS AND THE IPG CANNOT BE CHARGED.

    Description of Event or Problem · 1

    A REPORT WAS RECEIVED THAT A PATIENT WILL UNDERGO A POCKET REVISION AND IPG REPLACEMENT DUE TO DIFFICULTY CHARGING. THE PATIENT HAS EXPERIENCED DIFFICULTY CHARGING SINCE BEING IMPLANTED. WHEN THE CHARGER IS PLACED OVER THE POCKET SITE THE CHARGER CONTINUOUSLY BEEPS AND THE IPG CANNOT BE CHARGED.

    Description of Event or Problem · 1

    A REPORT WAS RECEIVED THAT A PATIENT WILL UNDERGO A POCKET REVISION AND IPG REPLACEMENT DUE TO DIFFICULTY CHARGING. THE PATIENT HAS EXPERIENCED DIFFICULTY CHARGING SINCE BEING IMPLANTED. WHEN THE CHARGER IS PLACED OVER THE POCKET SITE THE CHARGER CONTINUOUSLY BEEPS AND THE IPG CANNOT BE CHARGED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    53803 PRECISION SPINAL CORD STIMULATOR LGW BOSTON SCIENTIFIC NEUROMODULATION SC-1110-02 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention