BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PRECISION

    MDR report key: 8212204 · Received January 3, 2019

    Report

    Report Number
    3006630150-2018-62565
    Event Type
    Injury
    Date Received
    January 3, 2019
    Date of Event
    September 24, 2018
    Report Date
    March 14, 2019
    Manufacturer
    BOSTON SCIENTIFIC NEUROMODULATION
    Product Code
    LGW
    UDI-DI
    08714729767688
    PMA / PMN Number
    P030017
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    SC-1110-02/(B)(4). DEVICE EVALUATION INDICATED THAT THE COMPLAINT WAS NOT VERIFIED. THE DEVICE FUNCTIONED NORMALLY PRIOR TO THE EXPLANT. THE CHARGE PROFILE INDICATED THAT THE MAXIMUM TEMPERATURE DURING CHARGING CYCLES IN THE PATIENTS BODY WAS 42.45 DEGREES CELSIUS, WITHIN THE EXPECTED RANGE. HOWEVER, THE DEVICE EXHIBITED POST EXPLANT DAMAGE; A BURN MARK ON THE CASE, EXCESSIVE BATTERY DEPLETION, LOW VH IMPEDANCE TO GROUND, AND EXCESSIVE SLEEP CURRENT DUE TO U1-ANALOG IC DAMAGE. THIS TYPE OF DAMAGE OCCURS WHEN THE IPG IS EXPOSED TO HIGH-VOLTAGE TRANSIENTS (REF: (B)(4)).

    Description of Event or Problem · 0

    A REPORT WAS RECEIVED THAT THE PATIENTS SYSTEM WAS HEATING UP DURING CHARGING. THE PATIENT UNDERWENT AN IPG AND LEAD REPLACEMENT PROCEDURE AND WAS DOING WELL POSTOPERATIVELY.

    Additional Manufacturer Narrative · 1

    MODEL NUMBER/CATALOG NUMBER: SC-2138-70; SERIAL NUMBER: (B)(4); MODEL/CATALOG DESCRIPTION: SCS 70CM III LEAD 8 CONTACT LEAD. MODEL NUMBER/CATALOG NUMBER: SC-2218-50; SERIAL NUMBER: (B)(4); MODEL/CATALOG DESCRIPTION: LINEAR ST LEAD KIT 50 CM.

    Description of Event or Problem · 1

    A REPORT WAS RECEIVED THAT THE PATIENTS SYSTEM WAS HEATING UP DURING CHARGING. THE PATIENT UNDERWENT AN IPG AND LEAD REPLACEMENT PROCEDURE AND WAS DOING WELL POSTOPERATIVELY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    5262 PRECISION STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF LGW BOSTON SCIENTIFIC NEUROMODULATION SC-1110-02 187824 08714729767688

    Patients

    Seq Age Sex Outcome Treatment
    1 65 YR Required Intervention