BEUDAMED
    FDA Adverse Event Injury Summary report: N

    WAVEWRITER ALPHA PRIME 16

    MDR report key: 21035069 · Received December 30, 2024

    Report

    Report Number
    3006630150-2024-09139
    Event Type
    Injury
    Date Received
    December 30, 2024
    Date of Event
    December 6, 2024
    Report Date
    December 30, 2024
    Manufacturer
    BOSTON SCIENTIFIC NEUROMODULATION CORPORATION
    Product Code
    LGW
    UDI-DI
    08714729985068
    PMA / PMN Number
    P030017
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN, 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 COMPONENTS INVOLVED IN THE EVENT: PRODUCT FAMILY: SCS-LINEAR LEADS UPN:(B)(4), MODEL: SC-2218-50 SERIAL:(B)(6), BATCH:7139931 /7143104, PRODUCT FAMILY: SCS-LEAD FIXATION, UPN: (B)(4), MODEL: SC-4316 SERIAL/BATCH:(B)(6).

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE PATIENT DEVELOPED INFECTION AT THE POCKET SITE. THE INFECTION WAS NOT DEVICE NOR PROCEDURE RELATED. ANTIBIOTICS WERE PRESCRIBED. THE PATIENT UNDERWENT FULL SPINAL CORD STIMULATOR (SCS) SYSTEM EXPLANT PROCEDURE. ALL EXPLANTED DEVICE COMPONENTS WILL NOT BE RETURNED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2436006 WAVEWRITER ALPHA PRIME 16 STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF LGW BOSTON SCIENTIFIC NEUROMODULATION CORPORATION SC-1416 225120 08714729985068

    Patients

    Seq Age Sex Outcome Treatment
    1 44 YR Male Required Intervention