BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SPECTRA WAVEWRITER

    MDR report key: 11766036 · Received May 3, 2021

    Report

    Report Number
    3006630150-2021-01906
    Event Type
    Injury
    Date Received
    May 3, 2021
    Date of Event
    November 1, 2020
    Report Date
    May 3, 2021
    Manufacturer
    BOSTON SCIENTIFIC NEUROMODULATION
    Product Code
    LGW
    PMA / PMN Number
    P030017
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NJ, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    DATE OF EVENT: EXACT DATE UNKNOWN, EVENT OCCURED IN (B)(6) 2020.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENTS LEADS HAD HIG IMPEDANCES. THE PHYSICIAN BELIEVED THE ISSUE WAS WITH THE IPG AND OPTED TO REPLACE THE IPG. HOWEVER, THE IMPEDANCES WERE STILL PRESENT WITH THE NEW IPG AND THE PHYSICIAN DID NOT WANT TO REVISE THE LEADS SINCE PATIENT WAS STILL RECEIVING PAIN RELIEF. THE PATIENT WAS DOING WELL POSTOPERATIVELY AND WAS REPROGRAMMED. THE EXPLANTED IPG WILL NOT BE RETURNED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    662244 SPECTRA WAVEWRITER STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF LGW BOSTON SCIENTIFIC NEUROMODULATION SC-1160

    Patients

    Seq Age Sex Outcome Treatment
    1 66 YR Required Intervention