BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    AVISTA MRI

    MDR report key: 11285906 · Received February 5, 2021

    Report

    Report Number
    3006630150-2021-00313
    Event Type
    Malfunction
    Date Received
    February 5, 2021
    Date of Event
    January 18, 2021
    Report Date
    August 9, 2021
    Manufacturer
    BOSTON SCIENTIFIC NEUROMODULATION
    Product Code
    LGW
    UDI-DI
    08714729904816
    PMA / PMN Number
    P030017
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE PATIENT HAD HIGH IMPEDANCES ON THE LEADS. IT WAS ALSO MENTIONED THAT A LEAD CHECK HAS BEEN PERFORMED AND UPON CHECKING THE LEAD THERE WAS A POTENTIAL FRACTURE OR SHORT CIRCUIT THAT WAS NOTED. ADDITIONAL INFORMATION WAS RECEIVED THAT THE PATIENT IS STILL NOTICING THE JOLTS TO THE SYSTEM. THE DATABASE ANALYSIS OF THE BATTERY DISCHARGE SHOWS SIGNS OF PREMATURE BATTERY DEPLETION. THE IMPEDANCE MEASUREMENTS REVEALED A LOW VALUE ON PORT C (1 CONTACT).

    Additional Manufacturer Narrative · 1

    APPROXIMATED BASED ON THE DATE THE MANUFACTURER BECAME AWARE OF THE EVENT. MODEL NUMBER/CATALOG NUMBER: SC-2408-56. SERIAL NUMBER: (B)(4). BATCH/LOT NUMBER: (B)(4). MODEL/CATALOG DESCRIPTION: AVISTA MRI PERC LEAD KIT 56 CM.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT HAD HIGH IMPEDANCES ON THE LEADS. IT WAS ALSO MENTIONED THAT A LEAD CHECK HAS BEEN PERFORMED AND UPON CHECKING THE LEAD THERE WAS A POTENTIAL FRACTURE OR SHORT CIRCUIT THAT WAS NOTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    180747 AVISTA MRI STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF LGW BOSTON SCIENTIFIC NEUROMODULATION SC-2408-56 19901481 08714729904816

    Patients

    Seq Age Sex Outcome Treatment
    1 56 YR Required Intervention