BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PRECISION

    MDR report key: 17761363 · Received September 15, 2023

    Report

    Report Number
    3006630150-2023-05590
    Event Type
    Injury
    Date Received
    September 15, 2023
    Date of Event
    February 27, 2023
    Report Date
    September 15, 2023
    Manufacturer
    BOSTON SCIENTIFIC NEUROMODULATION
    Product Code
    LGW
    UDI-DI
    08714729888734
    PMA / PMN Number
    P030017
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    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-ADAPTERS, UPN: M365SC9218150, MODEL: SC-9218-15, SERIAL: (B)(6), BATCH: 7074421. PRODUCT FAMILY: DBS-ADAPTERS, UPN: M365DB9218550, MODEL: DB-9218-55, SERIAL: (B)(6), BATCH: 7062233. PRODUCT FAMILY: SCS-IPG-R, UPN: M365SC11600, MODEL: SC-1160, SERIAL: (B)(6), BATCH: 367592.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE PATIENT EXPERIENCED UNDESIRED SENSATIONS IN THEIR HEAD RELATED TO STIMULATION. THE PATIENT UNDERWENT A PROCEDURE (REPORTED IN MFR# 3006630150-2023-01540) TO REVISE THE SPINAL CORD STIMULATION (SCS) SYSTEM IN RESPONSE TO THE UNDESIRED SENSATIONS. HOWEVER, THE PATIENT CONTINUED TO EXPERIENCE THESE SENSATIONS POSTOPERATIVELY, AND UNDERWENT A SECOND PROCEDURE. PRIOR TO THE SECOND PROCEDURE THE PHYSICIAN WAS UNABLE TO CONNECT TO THE IMPLANTABLE PULSE GENERATOR (IPG) SINCE THE DEVICE HAD BEEN OFF SINCE THE PREVIOUS PROCEDURE; PRE-OPERATIVE CHARGING EFFORTS IN THE HOSPITAL WERE UNSUCCESSFUL. THEREFORE, THE IPG AND NON-BOSTON SCIENTIFIC LEADS WERE REPLACED, AND THE LEAD ADAPTERS WERE REMOVED. THE PATIENT DID WELL POSTOPERATIVELY AND RECEIVED ADEQUATE COVERAGE. PHYSICAL ANALYSIS OF THE DEVICES COULD NOT BE COMPLETED IN OUR LABORATORY, AS THEY WERE DISCARDED BY THE FACILITY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1041102 PRECISION STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF LGW BOSTON SCIENTIFIC NEUROMODULATION SC-9218-15 7074801 08714729888734

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Required Intervention