BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SPECTRA WAVEWRITER

    MDR report key: 12299951 · Received August 10, 2021

    Report

    Report Number
    3006630150-2021-04394
    Event Type
    Injury
    Date Received
    August 10, 2021
    Date of Event
    July 19, 2021
    Report Date
    August 19, 2021
    Manufacturer
    BOSTON SCIENTIFIC NEUROMODULATION
    Product Code
    LGW
    UDI-DI
    08714729951254
    PMA / PMN Number
    P030017
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE PATIENT UNDERWENT A REPLACEMENT PROCEDURE DUE TO AN UNKNOWN REASON. NO DEVICE MALFUNCTION WAS SUSPECTED. THE EXPLANTED DEVICES WILL NOT BE RETURNED. NO FURTHER INFORMATION HAS BEEN OBTAINED DESPITE GOOD FAITH EFFORTS. ADDITIONAL INFORMATION WAS RECEIVED THAT THE PATIENT EXPERIENCED LOSS OF STIMULATION DUE TO LEAD MIGRATION. THE PATIENT WAS DOING WELL POSTOPERATIVELY.

    Additional Manufacturer Narrative · 1

    DATE OF EVENT: APPROXIMATED BASED ON THE DATE THE MANUFACTURER BECAME AWARE OF THE EVENT. ADDITIONAL SUSPECT MEDICAL DEVICE COMPONENTS INVOLVED IN THE EVENT: PRODUCT FAMILY: SCS-LINEAR LEADS, UPN: M365SC2317700, MODEL: SC-2317-70, SERIAL: (B)(4), BATCH: 5100119/5100349.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT UNDERWENT A REPLACEMENT PROCEDURE DUE TO AN UNKNOWN REASON. NO DEVICE MALFUNCTION WAS SUSPECTED. THE EXPLANTED DEVICES WILL NOT BE RETURNED. NO FURTHER INFORMATION HAS BEEN OBTAINED DESPITE GOOD FAITH EFFORTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1199016 SPECTRA WAVEWRITER STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF LGW BOSTON SCIENTIFIC NEUROMODULATION SC-1160 359194 08714729951254

    Patients

    Seq Age Sex Outcome Treatment
    1 51 YR Required Intervention