BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INTERSTIM II

    MDR report key: 2543160 · Received April 20, 2012

    Report

    Report Number
    3004209178-2012-02535
    Event Type
    Injury
    Date Received
    April 20, 2012
    Report Date
    March 27, 2012
    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
    TN, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    PRODUCT ID, 3093-33 LOT# V072754, IMPLANTED: 2008 (B)(6), EXPLANTED: PRODUCT TYP LEAD; PRODUCT ID, 3037 SERIAL# (B)(4), PRODUCT TYP PROGRAMMER, PATIENT. (B)(4).

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION FROM THE PATIENT'S HEALTH CARE PROVIDER (HCP) SHOWED THE PATIENT'S DEVICE WAS REMOVED DUE TO PAIN AT THE INS SITE. THE DATE OF EXPLANT WAS NOT REPORTED. THE PATIENT OUTCOME WAS REPORTED AS 'NO INJURY.'

    Description of Event or Problem · 1

    A POWER-ON-RESET (POR) CONDITION WAS REPORTED. THE PATIENT WAS NOT ABLE TO ADJUST STIMULATION AND THE PATIENT PROGRAMMER DISPLAYED A "CALL YOUR DOCTOR" ICON WHEN HE ATTEMPTED TO TURN THE IMPLANTABLE NEUROSTIMULATOR ON. THE PATIENT HAD HIS PACEMAKER TESTED THE WEEK PRIOR TO REPORT, AND THE INS WAS WORKING FINE ONE TO TWO DAYS PRIOR TO REPORT. THE PATIENT USUALLY TURNED HIS INS OFF WHILE DRIVING, AND DID NOT REMEMBER IF HE TURNED IT BACK ON AFTER HIS VISIT TO THE VA TWO DAYS PRIOR TO REPORT. ADDITIONAL INFORMATION HAS BEEN REQUESTED BUT WAS NOT AVAILABLE AS OF THE DATE OF THIS REPORT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 INTERSTIM II STIMULATOR, ELECTRICAL, IMPLANTABLE, FOR INCONTINENCE EZW MEDTRONIC MED REL MEDTRONIC PUERTO RICO 3058

    Patients

    Seq Age Sex Outcome Treatment
    1 00078 YR Required Intervention