BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INTERSTIM II

    MDR report key: 3050338 · Received April 10, 2013

    Report

    Report Number
    3004209178-2013-05860
    Event Type
    Injury
    Date Received
    April 10, 2013
    Report Date
    March 19, 2013
    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
    FL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    PRODUCT ID 3037, SERIAL# (B)(4); PRODUCT TYPE PROGRAMMER, PATIENT PRODUCT ID 3 093-28 LOT# V675653, IMPLANTED: 2011 (B)(6), EXPLANTED: 2013 (B)(6); PRODUCT TYPE LEAD PRODUCT ID 3093-28 LOT# V67565, IMPLANTED: 2011 (B)(6), EXPLANTED: 2013 (B)(6). (B)(4).

    Additional Manufacturer Narrative · 1

    FINAL ANALYSIS OF NEUROSTIMULATOR MODEL 3058 (LOT # NJY167893H ) SHOWED NO ANOMALY FOUND. FINAL ANALYSIS OF LEAD MODEL 3093-28 SHOWED STIM LEAD PROXIMAL END CONDUCTOR SHORT BETWEEN CIRCUITS (DRY CONDITIONS).

    Additional Manufacturer Narrative · 1

    PRODUCT ID: 3037 LOT# SERIAL# (B)(4), PRODUCT TYPE PROGRAMMER, PATIENT PRODUCT ID: 3 093-28 LOT# V675653, IMPLANTED: 2011 (B)(6), PRODUCT TYPE LEAD. (B)(4).

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION RECEIVED NOTED THAT THERE WAS A SHORTAGE IN THE LEAD. THE LEAD WAS EXPLANTED AND REPLACED. THERE WAS AN IMPEDANCE ISSUE, LOW, LESS THAN 50. IMPEDANCE TESTING AND REPROGRAMMING HAD BEEN DONE. THE INS WAS ALSO EXPLANTED AND REPLACED. BATTERY DEPLETION WAS NOTED AS NORMAL. IMPEDANCE ISSUE, LOW, LESS THAN 50 WAS NOTED. IMPEDANCE TESTING SHOWED LESS THAN 50 ON SOME ELECTRODES. PATIENT HAD BEEN REPROGRAMMED MULTIPLE TIMES. PATIENT REPORTED A LOSS OF THERAPEUTIC EFFECT. REGARDING PATIENT SYMPTOMS IT WAS NOTED LESS THAN 50% THERAPY RELIEF. PATIENT STATUS AT TIME OF THE REPORTING WAS ALIVE - NO INJURY. IF ADDITIONAL INFORMATION IS RECEIVED, A FOLLOW UP REPORT WILL BE SENT.

    Description of Event or Problem · 1

    FOLLOW UP INFORMATION RECEIVED REPORTED THAT THE CAUSE OF THE LOW IMPEDANCES ON THE IMPLANTABLE NEUROSTIMULATOR (INS) COULD NOT BE D ETERMINED BUT DID RESOLVE FOLLOWING THE REPLACEMENT PROCEDURE. IF ADDITIONAL INFORMATION IS RECEIVED, A FOLLOW-UP REPORT WILL BE SENT.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT WAS EXPERIENCING A LOSS OF THERAPEUTIC EFFECT. THE PATIENT WAS " PEEING ALL OVER THE PLACE", AND THIS STARTED ABOUT 3 DAYS AGO. THE PATIENT COULD FEEL THE STIMULATION, AND THE STIMULATION WAS "ENOUGH TO PROTECT ME A LITTLE BIT". THE AMPLITUDE WOULD ONLY GO UP TO 5.2V. THE PATIENT'S DAUGHTER NORMALLY USED THE PROGRAMMER FOR HER. ADDITIONAL INFORMATION WAS REPORTED ON (B)(6) 2013 AND NOTED THAT THE PATIENT NEVER HAD THERAPEUTIC EFFECT. THE PATIENT WAS TEMPORARILY STAYING AT A REHAB FACILITY. IT WAS REPORTED THAT THE DEVICE WAS NOT WORKING FOR THE PAST 2 DAYS. "NOT GETTING ANY KIND" "DIAL IN AND GOT NOTHING" IT WAS NOTED THAT THE PATIENT WAS CONFUSED. THEY WERE NOT GETTING UP THE POWER AND STRONG SIGNAL. IT WAS NOTED THAT THE DEVICE WAS CURRENTLY ON PROGRAM 4 AT 6.30V AND STIMULATION WAS ON. IF ADDITIONAL INFORMATION IS RECEIVED, A FOLLOW UP REPORT WILL BE SENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    149714 INTERSTIM II STIMULATOR, ELECTRICAL, IMPLANTABLE, FOR INCONTINENCE EZW MEDTRONIC MED REL MEDTRONIC PUERTO RICO 3058

    Patients

    Seq Age Sex Outcome Treatment
    1 00069 YR Required Intervention