BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SPECTRA WAVEWRITER

    MDR report key: 11607353 · Received April 2, 2021

    Report

    Report Number
    3006630150-2021-01334
    Event Type
    Injury
    Date Received
    April 2, 2021
    Date of Event
    December 1, 2020
    Report Date
    April 1, 2021
    Manufacturer
    BOSTON SCIENTIFIC NEUROMODULATION
    Product Code
    LGW
    UDI-DI
    08714729951254
    PMA / PMN Number
    P030017
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    EXACT DATE UNKNOWN, EVENT OCCURRED IN (B)(6) 2020. ADDITIONAL SUSPECT MEDICAL DEVICE COMPONENTS INVOLVED IN THE EVENT: PRODUCT FAMILY: SCS-LINEAR LEADS, UPN: (B)(4), MODEL: SC-2218-50, SERIAL: (B)(4), BATCH: 7076455/7076459. PRODUCT FAMILY: SCS-LINEAR LEADS, UPN: (B)(4), MODEL: SC-2218-70, SERIAL: (B)(4), BATCH: 5163647.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT WAS EXPERIENCING PAIN AT THE IPG AND LEAD SITES. IT WAS OBSERVED THAT THE IPG SEEMED TO BE LEANING OUT WITH SUPERIOR ASPECT MORE SUPERFICIAL. THE PATIENT UNDERWENT A REVISION PROCEDURE WHERE THE IPG POCKET WAS MOVED FROM THE LEFT TO THE RIGHT SIDE. THE PATIENT WAS DOING WELL POST-OPERATIVELY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    506984 SPECTRA WAVEWRITER STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF LGW BOSTON SCIENTIFIC NEUROMODULATION SC-1160 364730 08714729951254

    Patients

    Seq Age Sex Outcome Treatment
    1 49 YR Required Intervention