BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SPECTRA WAVEWRITER

    MDR report key: 14917061 · Received July 5, 2022

    Report

    Report Number
    3006630150-2022-03299
    Event Type
    Injury
    Date Received
    July 5, 2022
    Date of Event
    February 3, 2021
    Report Date
    July 5, 2022
    Manufacturer
    BOSTON SCIENTIFIC NEUROMODULATION
    Product Code
    LGW
    UDI-DI
    08714729951254
    PMA / PMN Number
    P030017
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    117

    Narratives

    Additional Manufacturer Narrative · 0

    EVENT DATE: EXACT DATE UNKNOWN, EVENT OCCURRED A COUPLE OF MONTHS. ADDITIONAL SUSPECT MEDICAL DEVICE COMPONENTS INVOLVED IN THE EVENT: PRODUCT FAMILY: SCS-LINEAR LEADS; UPN: M365SC2218500; MODEL: SC-2218-50; SERIAL: (B)(4); BATCH: 5160906/5164039.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE PATIENT WAS EXPERIENCING PAIN AT THE IPG POCKET SITE TRAVELLING OVER TO THE MIDLINE INCISION. THE PATIENT HAD A REPROGRAMMING AND GOOD COVERAGE WAS REPORTED BUT THE PATIENT WAS STILL EXPERIENCING THE POCKET DISCOMFORT. IT WAS NOTED THAT THE PAIN WAS A RESULT OF A SCAR TISSUE. THE PATIENT WAS RECOMMENDED FOR A SCAR TISSUE MASSAGE AND NO FURTHER INTERVENTION WAS DONE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    398149 SPECTRA WAVEWRITER STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF LGW BOSTON SCIENTIFIC NEUROMODULATION SC-1160 358311 08714729951254

    Patients

    Seq Age Sex Outcome Treatment
    1 86 YR Female Required Intervention