BEUDAMED
    FDA Adverse Event Injury Summary report: N

    WAVEWRITER ALPHA PRIME

    MDR report key: 18274050 · Received December 6, 2023

    Report

    Report Number
    3006630150-2023-07656
    Event Type
    Injury
    Date Received
    December 6, 2023
    Date of Event
    November 13, 2023
    Report Date
    December 29, 2023
    Manufacturer
    BOSTON SCIENTIFIC NEUROMODULATION
    Product Code
    LGW
    UDI-DI
    08714729985075
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    BLOCK B3: APPROXIMATED BASED ON THE DATE THE MANUFACTURER BECAME AWARE OF THE EVENT. ADDITIONAL SUSPECT MEDICAL DEVICE COMPONENT INVOLVED IN THE EVENT: PRODUCT FAMILY: SCS-PADDLE LEADS; UPN: M365SC8336700; MODEL: SC-8336-70; SERIAL: (B)(6); BATCH: 7070156.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT DURING AN IMPLANTABLE PULSE GENERATOR (IPG) REVISION PROCEDURE, THE LEAD GOT STUCK FROM THE IPG. THE PATIENT UNDERWENT A BATTERY AND LEAD REPLACEMENT PROCEDURE. ADDITIONAL INFORMATION RECEIVED THAT THE PATIENT WANTS THE BATTERY TO BE PLACED HIGHER. THE PATIENT WAS DOING WELL AFTER THE PROCEDURE. THE EXPLANTED DEVICE WAS RETAINED AT THE FACILITY.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT DURING AN IMPLANTABLE PULSE GENERATOR (IPG) REVISION PROCEDURE, THE LEAD GOT STUCK FROM THE IPG. THE PATIENT UNDERWENT A BATTERY AND LEAD REPLACEMENT PROCEDURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    73332 WAVEWRITER ALPHA PRIME STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF LGW BOSTON SCIENTIFIC NEUROMODULATION SC-1432 220908 08714729985075

    Patients

    Seq Age Sex Outcome Treatment
    1 62 YR Female Required Intervention