BEUDAMED
    FDA Adverse Event Injury Summary report: N

    WAVEWRITER ALPHA PRIME 16

    MDR report key: 20279392 · Received September 23, 2024

    Report

    Report Number
    3006630150-2024-06362
    Event Type
    Injury
    Date Received
    September 23, 2024
    Date of Event
    September 3, 2024
    Report Date
    December 26, 2024
    Manufacturer
    BOSTON SCIENTIFIC NEUROMODULATION CORPORATION
    Product Code
    LGW
    UDI-DI
    08714729985068
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, 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 Manufacturer Narrative · 0

    ADDITIONAL SUSPECT MEDICAL DEVICE COMPONENT INVOLVED IN THE EVENT: PRODUCT FAMILY: SCS-LINEAR LEADS UPN: M365SC2218700 MODEL: SC-2218-70 SERIAL: (B)(6). BATCH: 7102315/7102290. ADDITIONAL SUSPECT MEDICAL DEVICE COMPONENT INVOLVED IN THE EVENT: PRODUCT FAMILY: SCS-LEAD FIXATION UPN: M365SC43180 MODEL: SC-4318. BATCH: 34155007.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT PATIENT HAD AN INFECTION AT THE DISTAL PORTION OF THE MIDLINE INCISION SITE. IT WAS NOTED THAT PATIENT EXPERIENCED SHORTNESS OF BREATH AND INCREASED PAIN AT THE SURGICAL SIGHT. THE PATIENT WAS PLACED UNDER ORAL ANTIBIOTICS AND WAS DOING BETTER.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT PATIENT HAD AN INFECTION AT THE DISTAL PORTION OF THE MIDLINE INCISION SITE. IT WAS NOTED THAT PATIENT EXPERIENCED SHORTNESS OF BREATH AND INCREASED PAIN AT THE SURGICAL SIGHT. THE PATIENT WAS PLACED UNDER ORAL ANTIBIOTICS AND WAS DOING BETTER. ADDITIONAL INFORMATION RECEIVED PATIENTS MIDLINE INCISION REMAINS INFECTED AND DRAINING.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT PATIENT HAD AN INFECTION AT THE DISTAL PORTION OF THE MIDLINE INCISION SITE. IT WAS NOTED THAT PATIENT EXPERIENCED SHORTNESS OF BREATH AND INCREASED PAIN AT THE SURGICAL SIGHT. THE PATIENT WAS PLACED UNDER ORAL ANTIBIOTICS AND WAS DOING BETTER. ADDITIONAL INFORMATION RECEIVED PATIENTS MIDLINE INCISION REMAINS INFECTED AND DRAINING. ADDITIONAL INFORMATION RECEIVED THAT PATIENT UNDERWENT A SPINAL CORD STIMULATOR EXPLANT PROCEDURE WHERE ALL DEVICES WERE REMOVED. THE EXPLANTED DEVICE WILL NOT BE RETURN AS IT WAS DISCARDED AT THE FACILITY. THE PATIENT WAS DOING WELL POST OPERATIVELY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1746823 WAVEWRITER ALPHA PRIME 16 STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF LGW BOSTON SCIENTIFIC NEUROMODULATION CORPORATION SC-1416 229856 08714729985068

    Patients

    Seq Age Sex Outcome Treatment
    1 68 YR Female Required Intervention