BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INTERSTIM

    MDR report key: 5893806 · Received August 22, 2016

    Report

    Report Number
    3004209178-2016-17357
    Event Type
    Injury
    Date Received
    August 22, 2016
    Date of Event
    February 13, 2016
    Report Date
    August 22, 2016
    Manufacturer
    MEDTRONIC MED REL MEDTRONIC PUERTO RICO
    Product Code
    EZW
    PMA / PMN Number
    P970004
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    INFORMATION REFERENCES THE MAIN COMPONENT OF THE SYSTEM AND OTHER APPLICABLE COMPONENTS ARE: PRODUCT ID: 3093-28, LOT# V001988, IMPLANTED: (B)(6) 2006, EXPLANTED: (B)(6) 2016, PRODUCT TYPE: LEAD.

    Additional Manufacturer Narrative · 1

    IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Description of Event or Problem · 1

    THE PATIENT REPORTED THEIR IMPLANTABLE NEUROSTIMULATOR (INS) HAD DEPLETED WHEN THE PATIENT REPORTED SHOCKING INCIDENTS AT THE INS SITE. THE HEALTHCARE PROFESSIONAL (HCP) OFFICE CONFIRMED THE INS BATTERY DEPLETED. THE PATIENT HAD THE INS REPLACED DUE TO NORMAL BATTERY DEPLETION AND WAS TOLD THE WIRE WAS REMOVED AS THE INSULATION HAD CORRODED. SINCE REPLACEMENT, THE SHOCKING HAD STOPPED. IT WAS STATED THEY NOTICED WHEN THE INS DEPLETED, WHICH WAS JUST 2 DAYS SHORT OF 10 YEARS FROM THE DATE OF IMPLANT, AND THEN THEY STARTED EXPERIENCING THE SHOCKING INCIDENTS. INDICATION FOR USE WAS URINARY DYSFUNCTION/SACRAL NERVE STIMULATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    545407 INTERSTIM STIMULATOR, ELECTRICAL, IMPLANTABLE, FOR INCONTINENCE EZW MEDTRONIC MED REL MEDTRONIC PUERTO RICO 3023

    Patients

    Seq Age Sex Outcome Treatment
    1 48 YR Required Intervention