BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PRECISION

    MDR report key: 8982358 · Received September 10, 2019

    Report

    Report Number
    3006630150-2019-04941
    Event Type
    Injury
    Date Received
    September 10, 2019
    Date of Event
    August 22, 2019
    Report Date
    October 17, 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 (SN: (B)(4)). DEVICE EVALUATION INDICATED THAT THE IPG PASSED ALL TESTS PERFORMED AND REVEALED NO ANOMALIES. SC-2208-70 (SN: (B)(4)). DEVICE EVALUATION INDICATED THAT THE DEVICE WAS CUT INTO PIECES THAT ADDED UP 70 CENTIMETERS. THE DEVICE DAMAGE WAS SIMILAR TO THE TYPICAL EXPLANT DAMAGE AND WAS NOT CONSIDERED A FAILURE. SC-2208-70 (SN: (B)(4)). DEVICE EVALUATION INDICATED THAT THE DEVICE WAS CUT INTO PIECES AND THE DISTAL PORTION (ABOUT 32 CENTIMETERS) WAS NOT RETURNED. THE DEVICE DAMAGE WAS SIMILAR TO THE TYPICAL EXPLANT DAMAGE AND WAS NOT CONSIDERED A FAILURE.

    Description of Event or Problem · 0

    A REPORT WAS RECEIVED THAT THE PATIENT HAD INADEQUATE PAIN RELIEF. THE PATIENT UNDERWENT AN EXPLANT PROCEDURE.

    Additional Manufacturer Narrative · 1

    MODEL NUMBER/CATALOG NUMBER: SC-2208-70, SERIAL NUMBER: (B)(4), BATCH/LOT NUMBER: 175938/188062, MODEL/CATALOG DESCRIPTION: ST LINEAR LEAD 70 CM.

    Description of Event or Problem · 1

    A REPORT WAS RECEIVED THAT THE PATIENT HAD INADEQUATE PAIN RELIEF. THE PATIENT UNDERWENT AN EXPLANT PROCEDURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    778071 PRECISION STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF LGW BOSTON SCIENTIFIC NEUROMODULATION SC-1110-02 191855 08714729767688

    Patients

    Seq Age Sex Outcome Treatment
    1 42 YR Required Intervention