BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INTERSTIM II

    MDR report key: 2907686 · Received January 10, 2013

    Report

    Report Number
    3004209178-2013-00422
    Event Type
    Injury
    Date Received
    January 10, 2013
    Report Date
    December 19, 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
    MN, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    PRODUCT ID, 3093-28 LOT# V073596, IMPLANTED: 2007 (B)(6), PRODUCT TYPE LEAD PRODUCT ID, 3037 LOT# SERIAL# (B)(4), PRODUCT TYPE PROGRAMMER, PATIENT. (B)(4).

    Description of Event or Problem · 1

    IN MFR # 3004209178-2012-04733-004, THE FOLLOWING INFORMATION WAS REPORTED: "IT WAS LATER REPORTED THEY WERE DOING A LEAD REVISION DUE TO POOR LEAD LOCATION AND NOTICED THE IMPLANTABLE NEUROSTIMULATOR (INS) SHOWED THAT CAPACITY WAS LESS THAN 50%. THE HEALTH CARE PROFESSIONAL WAS CONCERNED BECAUSE, THE DEVICE HAD BEEN IMPLANTED ABOUT SIX MONTHS PRIOR. IT WAS NOTED, THE PATIENT HAD BEEN RUNNING STIMULATION AROUND 10 VOLTS. LONGEVITY CALCULATION WAS DONE TO CALCULATE ESTIMATION OF INS LIFE. CALCULATION WAS RUN USING 8 VOLTS, 210 MICROSECONDS AND 14 HERTZ WHICH GAVE 8 MONTHS TO END OF SERVICE ESTIMATE. THE DOCTOR WANTED TO REPLACE BATTERY BECAUSE CAPACITY HAD BEEN REDUCED." ADDITIONAL REVIEW INDICATES THIS INFORMATION PERTAINS TO THIS MANUFACTURER'S REPORT. ANY ADDITIONAL INFORMATION RELATED TO THE BATTERY ISSUE EVENT WILL BE REPORTED IN THIS REPORT. ADDITIONAL INFORMATION RECEIVED ABOUT THE EVENT ALSO INDICATED THAT THE BATTERY ISSUE WAS RESOLVED AFTER THE LEAD REVISION WAS COMPLETED. THE PATIENT'S STATUS WAS CORRECTED AFTER THE REVISION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    14916 INTERSTIM II STIMULATOR, ELECTRICAL, IMPLANTABLE, FOR INCONTINENCE EZW MEDTRONIC MED REL MEDTRONIC PUERTO RICO 3058

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention