BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SPECTRA WAVEWRITER

    MDR report key: 10686341 · Received October 15, 2020

    Report

    Report Number
    3006630150-2020-04898
    Event Type
    Injury
    Date Received
    October 15, 2020
    Date of Event
    July 1, 2020
    Report Date
    October 15, 2020
    Manufacturer
    BOSTON SCIENTIFIC NEUROMODULATION
    Product Code
    LGW
    UDI-DI
    08714729951254
    PMA / PMN Number
    P030017
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CO, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    APPROXIMATED BASED ON THE DATE THE MANUFACTURER BECAME AWARE OF THE EVENT. ADDITIONAL SUSPECT MEDICAL DEVICE COMPONENTS INVOLVED IN THE EVENT: PRODUCT FAMILY: LINEAR ST LEAD KIT 70 CM, UPN: (B)(4), MODEL: SC-2218-70, SERIAL: (B)(4), BATCH: 5071791/5061457.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT FOLLOWING A POCKET REVISION PROCEDURE (MFR REPORT 3006630150-2020-03005) THE PATIENT WAS HAVING DIFFICULTY CHARGING IPG AND THE POCKET SITE WAS STILL SWOLLEN. IT WAS NOTED THAT THE PATIENTS IPG SITE HAD OPENED AND ONE OF THE WIRES WAS STICKING OUT THROUGH THE SKIN. THE PHYSICIAN BELIEVED THAT PATIENT WAS HAVING SEVERE HEALING ISSUES DUE TO HEALTH PROBLEMS AND THE PATIENTS SKIN WAS VERY THIN. THE PATIENT UNDERWENT AN EXPLANT PROCEDURE. ALL DEVICE COMPONENTS WERE EXPLANTED AND WERE NOT RETURNED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1147786 SPECTRA WAVEWRITER STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF LGW BOSTON SCIENTIFIC NEUROMODULATION SC-1160 339526 08714729951254

    Patients

    Seq Age Sex Outcome Treatment
    1 73 YR Required Intervention