BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SPECTRA WAVEWRITER

    MDR report key: 8858126 · Received August 2, 2019

    Report

    Report Number
    3006630150-2019-04016
    Event Type
    Injury
    Date Received
    August 2, 2019
    Date of Event
    June 25, 2019
    Report Date
    September 20, 2019
    Manufacturer
    BOSTON SCIENTIFIC NEUROMODULATION
    Product Code
    LGW
    UDI-DI
    08714729951254
    PMA / PMN Number
    P030017
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    SC-1160 (SN (B)(4)). DEVICE EVALUATION INDICATED THAT THE DEVICE PASSED ALL TESTS PERFORMED. SC-2317-50 (SN (B)(4)). DEVICE EVALUATION INDICATED THAT THE LEAD WAS CLEANLY CUT DURING THE EXPLANT. X-RAY INSPECTION FOUND NO OTHER CABLE FRACTURES EXCEPT THE CUT. THE DEVICE DAMAGE WAS SIMILAR TO THE TYPICAL EXPLANT DAMAGE AND WAS NOT CONSIDERED A FAILURE. SC-2317-50 (SN (B)(4)). DEVICE EVALUATION INDICATED THAT THE DEVICE PASSED ALL TESTS PERFORMED.

    Description of Event or Problem · 0

    A REPORT WAS RECEIVED THAT THE PATIENT HAD INADEQUATE STIMULATION AND UNDERWENT AN EXPLANT PROCEDURE.

    Additional Manufacturer Narrative · 1

    CONCOMITANT MEDICAL PRODUCTS: MODEL NUMBER/CATALOG NUMBER: SC-2317-50, SERIAL NUMBER: (B)(4), BATCH/LOT NUMBER: 5097336/5102459, MODEL/CATALOG DESCRIPTION: INFINION CX LEAD KIT, 50CM.

    Description of Event or Problem · 1

    A REPORT WAS RECEIVED THAT THE PATIENT HAD INADEQUATE STIMULATION AND UNDERWENT AN EXPLANT PROCEDURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    649498 SPECTRA WAVEWRITER STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF LGW BOSTON SCIENTIFIC NEUROMODULATION SC-1160 352553 08714729951254

    Patients

    Seq Age Sex Outcome Treatment
    1 85 YR Required Intervention