BEUDAMED
    FDA Adverse Event Injury Summary report: N

    WAVEWRITER ALPHA 16

    MDR report key: 15090396 · Received July 23, 2022

    Report

    Report Number
    3006630150-2022-03643
    Event Type
    Injury
    Date Received
    July 23, 2022
    Date of Event
    July 12, 2022
    Report Date
    September 30, 2022
    Manufacturer
    BOSTON SCIENTIFIC NEUROMODULATION
    Product Code
    LGW
    UDI-DI
    08714729985082
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IT
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    ADDITIONAL SUSPECT MEDICAL DEVICE COMPONENTS INVOLVED IN THE EVENT: PRODUCT FAMILY: SCS-LINEAR LEADS; UPN: M365SC2218500; MODEL: SC-2218-50; SERIAL: (B)(6); BATCH: 7094991. PRODUCT FAMILY: SCS-LINEAR LEADS UPN: M365SC2366700; MODEL: SC-2366-70; SERIAL: (B)(6); BATCH: 7073087.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT FOLLOWING THE IMPLANT PROCEDURE WHEN THE INITIAL PROGRAMMING WAS ATTEMPTED THE PATIENT DID NOT FEEL ANY STIMULATION AND NO THERAPY WAS PROVIDED. RE-PROGRAMMING WAS ATTEMPTED AGAIN THE NEXT DAY, BUT THE PATIENT STATED NO THERAPY WAS PROVIDED. THE PATIENT UNDERWENT A REVISION PROCEDURE IN WHICH THE LEADS WERE DISCONNECTED FROM THE IPG AND CONNECTED TO AN EXTERNAL OR CABLE TO CONFIRM THEY WORK. THE PATIENT IS DOING WELL POST-OPERATIVELY.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT FOLLOWING THE IMPLANT PROCEDURE WHEN THE INITIAL PROGRAMMING WAS ATTEMPTED THE PATIENT DID NOT FEEL ANY STIMULATION AND THERAPY WAS NOT PROVIDED. RE-PROGRAMMING WAS ATTEMPTED AGAIN THE FOLLOWING DAY, BUT THE PATIENT STATED NOT FEELING ANY STIMULATION AND NO THERAPY WAS PROVIDED. THE PATIENT UNDERWENT A REVISION PROCEDURE IN WHICH THE LEADS WERE DISCONNECTED FROM THE IMPLANTABLE PULSE GENERATOR (IPG) AND CONNECTED TO AN EXTERNAL OR CABLE TO CONFIRM THAT THE LEADS WORKED. IT WAS DETERMINED THAT THE LEADS MIGRATED, IMAGING WAS NOT PERFORMED TO CONFIRM MIGRATION. THE PHYSICIAN EXPLANTED THE TWO LEADS, THE (IPG) REMAINED IMPLANTED. THE PATIENT IS DOING WELL POSTOPERATIVELY.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT FOLLOWING THE IMPLANTABLE PULSE GENERATOR (IPG) AND LEAD IMPLANT PROCEDURE, WHEN THE INITIAL PROGRAMMING WAS ATTEMPTED THE PATIENT DID NOT FEEL ANY STIMULATION AND THERAPY WAS NOT PROVIDED. RE-PROGRAMMING WAS ATTEMPTED AGAIN THE NEXT DAY, BUT THE PATIENT STATED NOT FEELING ANY STIMULATION AND NO THERAPY WAS PROVIDED. THE FOLLOWING DAY THE PATIENT UNDERWENT A REVISION PROCEDURE IN WHICH THE LEADS WERE DISCONNECTED FROM THE IPG AND CONNECTED TO AN EXTERNAL OR CABLE TO CHECK THE LEADS. THE PHYSICIAN ASSESSED THAT ONE OF THE LEADS MIGRATED. THE LEAD WAS EXPLANTED AND A NEW LEAD WAS IMPLANTED. STIMULATION AND THERAPY WERE NOT ADEQUATE THEREFORE THE THIRD LEAD WAS EXPLANTED TWO WEEKS LATER. THE PATIENT IS DOING WELL POSTOPERATIVELY. THE LEADS WILL NOT BE RETURNED FOR ANALYSIS AS THEY WERE DISCARDED BY THE FACILITY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    117664 WAVEWRITER ALPHA 16 STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF LGW BOSTON SCIENTIFIC NEUROMODULATION SC-1216 540079 08714729985082

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Required Intervention