BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SPECTRA WAVEWRITER

    MDR report key: 10177810 · Received June 22, 2020

    Report

    Report Number
    3006630150-2020-02545
    Event Type
    Injury
    Date Received
    June 22, 2020
    Date of Event
    May 22, 2020
    Report Date
    June 22, 2020
    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 · 1

    ADDITIONAL SUSPECT MEDICAL DEVICE COMPONENT INVOLVED IN THE EVENT: PRODUCT FAMILY: SCS-PADDLE LEADS; UPN: M365SC8336500; MODEL: SC-8336-50; SERIAL: (B)(4); BATCH: 7070705.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT DEVELOPED LOWER EXTREMITY WEAKNESS POSTOPERATIVELY. A COMPUTERIZED TOMOGRAPHY SCAN WAS PERFORMED, AND PHYSICIAN STATED THAT THERE WAS NO HEMATOMA AND MILD STENOSIS PRESENT AT THE PADDLE SITE. IT WAS NOT DEVICE RELATED PER PHYSICIAN. THE PATIENT UNDERWENT AN IPG AND LEAD EXPLANT PROCEDURE AND WAS REFERRED TO A REHAB HOSPITAL UPON A MILD IMPROVEMENT OF SYMPTOMS. THE EXPLANTED LEAD AND IPG WERE DISCARDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    646241 SPECTRA WAVEWRITER STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF LGW BOSTON SCIENTIFIC NEUROMODULATION SC-1160 365023 08714729951254

    Patients

    Seq Age Sex Outcome Treatment
    1 81 YR Required Intervention