BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INTERSTIM

    MDR report key: 2539666 · Received April 18, 2012

    Report

    Report Number
    3007566237-2012-00805
    Event Type
    Malfunction
    Date Received
    April 18, 2012
    Report Date
    March 21, 2012
    Manufacturer
    MEDTRONIC MED REL MEDTRONIC PUERTO RICO
    Product Code
    EZW
    PMA / PMN Number
    P970004
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    LEAD MODEL 3889-28, LOT # V881399, IMPLANTED: (B)(6) 2012, EXPLANTED: NA; EXTENSION MODEL 3095-10, SERIAL # (B)(4), IMPLANTED: (B)(6) 2012, EXPLANTED: NA.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT LOW IMPEDANCES WERE FOUND ON ELECTRODE COMBINATION 0-3. IT WAS UNCLEAR IF THESE MEASUREMENTS WERE TAKEN PRE-OP, INTRA-OP OR POST-OP. FOLLOW-UP INFORMATION INDICATED THAT ALL FOUR OF THE PATIENT'S PROGRAMS WERE WORKING AND THAT THE PATIENT EXPERIENCED A ''POSITIVE [POST-OP] OUTCOME.'' ADDITIONAL INFORMATION HAD BEEN REQUESTED, BUT WAS NOT AVAILABLE AS OF THE DATE OF THIS REPORT.

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION RECEIVED REPORTED THAT THERE WAS NO NEGATIVE OUTCOME. THE BATTERY WAS REPROGRAMMED POST IMPLANT AND ALL READINGS WERE WITHIN ACCEPTABLE RANGE. IF ADDITIONAL INFORMATION BECOMES AVAILABLE, A FOLLOW-UP REPORT WILL BE SENT.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1