BEUDAMED
    FDA Adverse Event Injury Summary report: N

    WAVEWRITER ALPHA?

    MDR report key: 21868256 · Received April 18, 2025

    Report

    Report Number
    3006630150-2025-02612
    Event Type
    Injury
    Date Received
    April 18, 2025
    Date of Event
    February 19, 2025
    Report Date
    April 18, 2025
    Manufacturer
    BOSTON SCIENTIFIC NEUROMODULATION CORPORATION
    Product Code
    LGW
    UDI-DI
    08714729985099
    PMA / PMN Number
    P030017
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    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-MRI. UPN: M365SC2408560. MODEL: SC-2408-56. SERIAL: (B)(6). BATCH: 7085584. PRODUCT FAMILY: SCS-LINEAR LEADS-MRI. UPN: M365SC2408560. MODEL: SC-2408-56. SERIAL: (B)(6). BATCH: 7082352. PRODUCT FAMILY: SCS-EXTENSION. UPN: M365SC3138350. MODEL: SC-3138-35. SERIAL: (B)(6). BATCH: 7087608. PRODUCT FAMILY: SCS-EXTENSION. UPN: M365SC3138350. MODEL: SC-3138-35. SERIAL: (B)(6). BATCH: 7087036. PRODUCT FAMILY: SCS-LEAD FIXATION-MRI. UPN: M365SC43190. MODEL: SC-4319. SERIAL: N/A. BATCH: 34432586.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE PATIENT EXPERIENCED AN INFECTION AT THE IMPLANTABLE PULSE GENERATOR (IPG) SITE WHICH STARTED AT THE SPINAL CORD STIMULATION (SCS) LEAD ANCHOR FIXATION SITE AND PASSED THROUGH THE TUNNEL AND SPREAD TO THE IPG SITE. THE PATIENT SYMPTOMS INCLUDED PAIN AT THE INFECTED SITE. THE PHYSICIAN ASSESSED THAT THE INFECTION WAS DEVICE RELATED, HOWEVER, ALSO ASSESSED THAT NOTHING HAPPENED DURING THE SCS PROCEDURE THAT MAY HAVE CAUSED OR CONTRIBUTED TO THE INFECTION. A CULTURE WAS TAKEN AND CONFIRMED METHICILLIN-RESISTANT STAPHYLOCOCCUS AUREUS (MRSA). DUE TO RENAL FAILURE, STRONG MEDICATION WAS AVOIDED, BUT VANCOMYCIN WAS ADMINISTERED. THE PATIENT UNDERWENT A PROCEDURE WHERE THE SCS SYSTEM WAS EXPLANTED. THE EXPLANTED DEVICES WILL NOT BE RETURNED AS THEY WERE DISCARDED BY THE MEDICAL FACILITY. POST OPERATIVELY, THERE WAS NO CHANGE TO PATIENTS STATUS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1775395 WAVEWRITER ALPHA? STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF LGW BOSTON SCIENTIFIC NEUROMODULATION CORPORATION SC-1232 758296 08714729985099

    Patients

    Seq Age Sex Outcome Treatment
    1 31 YR Female Required Intervention