BEUDAMED
    FDA Adverse Event Injury Summary report: N

    WAVEWRITER ALPHA 16

    MDR report key: 15095461 · Received July 25, 2022

    Report

    Report Number
    3006630150-2022-03644
    Event Type
    Injury
    Date Received
    July 25, 2022
    Date of Event
    July 12, 2022
    Report Date
    October 5, 2022
    Manufacturer
    BOSTON SCIENTIFIC NEUROMODULATION
    Product Code
    LGW
    UDI-DI
    08714729985082
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SP
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    ADDITIONAL SUSPECT MEDICAL DEVICE COMPONENT INVOLVED IN THE EVENT: PRODUCT FAMILY: SCS-PADDLE LEADS; UPN: M365SC8216500; MODEL: SC-8216-50; SERIAL: (B)(4); BATCH: 7072720.

    Additional Manufacturer Narrative · 0

    ADDITIONAL SUSPECT MEDICAL DEVICE COMPONENT INVOLVED IN THE EVENT: PRODUCT FAMILY: SCS-PADDLE LEADS. UPN: M365SC8216500. MODEL: SC-8216-50. SERIAL: (B)(6). BATCH: 7072720. THE RETURNED DEVICES WERE ANALYZED, THE PROXIMAL PORTION OF THE LEAD REMAINED IN PORT C AFTER BEING CUT DURING THE PROCEDURE. THE PROXIMAL TIP REMOVED FROM THE PORT REVEALED THAT CONTACT #8 WAS LOCKED DOWN BY THE SETSCREW WITHOUT BEING INSERTED FULLY INTO THE PORT, WHICH WOULD RESULT IN THE IMPEDANCE ANOMALY. THE IPG PASSED THE IMPEDANCE TEST AND REVEALED NORMAL DEVICE CHARACTERISTICS. A LABELING REVIEW WAS PERFORMED ON THE IPG AND LEAD INSTRUCTIONS FOR USE, IFU. THERE WAS NO EVIDENCE THAT THE DEVICE WAS USED IN A MANNER INCONSISTENT WITH THE LABELED INDICATIONS. ADDITIONALLY IT STATES TO FULLY INSERT THE LEADS, INTO THE IPG PORTS, BEING CAREFUL NOT TO STRESS OR BEND THE PROXIMAL END OF THE LEAD. WHEN THE LEAD IS PROPERLY INSERTED, THE LEAD WILL STOP AND THE RETENTION RING WILL BE LOCATED UNDER THE SETSCREW BASED ON ALL AVAILABLE INFORMATION, ENGINEERS ARE ABLE TO CONFIRM THE ROOT CAUSE OF THE EVENT AS UNINTENDED USE ERROR CAUSED OR CONTRIBUTED TO EVENT. THE DEVICES WERE RETURNED AND ANALYZED, AS SUCH PHYSICAL ANALYSIS WAS CONDUCTED, RECORD REVIEW REVEALED NO ADDITIONAL INFORMATION RELATED TO THE COMPLAINT.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT WHILE IMPLANTING THE IPG, IMPLANTABLE PULSE GENERATOR, DURING THE SECOND PHASE OF THE SCS, SPINAL CORD STIMULATOR, PROCEDURE HIGH IMPEDANCES WERE OBSERVED ON THE PREVIOUSLY IMPLANTED LEAD. THE LEAD WAS IMPLANTED INTO PORT C OF THE IPG WHEN THE HIGH IMPEDANCES WERE OBSERVED. THE PHYSICIAN ATTEMPTED TO REMOVE THE LEAD FROM THE PORT BUT WAS UNABLE TO DO SO. HE ATTEMPTED TO UNSCREW IT BUT UNSCREWED IT TOO MUCH AND THE SCREW CAME OUT OF THE SEALING PORT. THE PHYSICIAN DECIDED TO CUT THE LEAD AND EXPLANT THE LEAD AND THE IPG AND IMPLANT A NEW LEAD AND IPG. THE PATIENT IS DOING WELL POST-OPERATIVELY.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT WHILE IMPLANTING THE IPG, IMPLANTABLE PULSE GENERATOR, DURING THE SECOND PHASE OF THE SCS, SPINAL CORD STIMULATOR, PROCEDURE HIGH IMPEDANCES WERE OBSERVED ON THE PREVIOUSLY IMPLANTED LEAD. THE LEAD WAS IMPLANTED INTO PORT C OF THE IPG WHEN THE HIGH IMPEDANCES WERE OBSERVED. THE PHYSICIAN ATTEMPTED TO REMOVE THE LEAD FROM THE PORT BUT WAS UNABLE TO DO SO. HE ATTEMPTED TO UNSCREW IT BUT UNSCREWED IT TOO MUCH AND THE SCREW CAME OUT OF THE SEALING PORT. THE PHYSICIAN DECIDED TO CUT THE LEAD AND EXPLANT THE LEAD AND THE IPG AND IMPLANT A NEW LEAD AND IPG. THE PATIENT IS DOING WELL POST-OPERATIVELY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    711184 WAVEWRITER ALPHA 16 STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF LGW BOSTON SCIENTIFIC NEUROMODULATION SC-1216 538710 08714729985082

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Required Intervention