BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INTERSTIM II

    MDR report key: 2982902 · Received February 28, 2013

    Report

    Report Number
    3004209178-2013-03158
    Event Type
    Malfunction
    Date Received
    February 28, 2013
    Report Date
    February 7, 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
    OK, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Additional Manufacturer Narrative · 1

    PRODUCT ID 3093-28, LOT# V826029, IMPLANTED: (B)(6) 2011, PRODUCT TYPE: LEAD. PRODUCT ID 3093-28, LOT# V826029, IMPLANTED: (B)(6) 2011, PRODUCT TYPE: LEAD. PRODUCT ID 3037, SERIAL# (B)(4), PRODUCT TYPE: PROGRAMMER, PATIENT. PRODUCT ID 3037, SERIAL# (B)(4), PRODUCT TYPE: PROGRAMMER, PATIENT. (B)(4).

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION RECEIVED REPORTED THAT ALL ELECTRODES HAD OPEN CIRCUITS EXCEPT THE CASE AND THE PAIR OF THE CASE AND 2. THE DEVICE WAS REPROGRAMMED TO NEW SETTINGS, AND THE RESULTS WERE UNKNOWN AT THE TIME OF THE REPORT. IT WAS REPORTED THAT THE PATIENT'S SIGNS AND SYMPTOMS INCLUDED DIFFICULTY VOIDING IN THE EVENINGS. THE PATIENT DID NOT REQUIRE HOSPITALIZATION. THE REPORTER STATED THAT THE PATIENT MAY REQUIRE A REVISION, BUT IT WAS UNKNOWN AT THE TIME OF THE REPORT. A FOLLOW-UP REPORT WILL BE MADE IF ADDITIONAL INFORMATION BECOMES AVAILABLE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT EXPERIENCED A LOSS OF THERAPEUTIC EFFECT. IT WAS STATED THAT THE PATIENT WAS AT HIS PHYSICIAN'S OFFICE ON (B)(6) 2013 FOR REPROGRAMMING AND DEVICE CHECK. IT WAS NOTED THAT BOTH WIRES WERE "BAD ONLY ONE OPTION WAS LEFT FOR PROGRAMMING", AND THAT THE BATTERIES WERE "MORE DEPLETED THAN THEY EXPECTED". IT WAS STATED THAT THERE WAS AN "ISSUE WITH THE LEADS". THE CALLER WAS REDIRECTED TO THE PATIENT'S HEALTH CARE PROVIDER TO DISCUSS HAVING PATIENT'S IMPLANTABLE NEUROSTIMULATORS EXPLANTED. ADDITIONAL INFORMATION HAS BEEN REQUESTED. IF ADDITIONAL INFORMATION BECOMES AVAILABLE, A SUPPLEMENTAL REPORT WILL BE FILED. REFERENCE MANUFACTURER REPORT NUMBER: 3004209178-2013-03156.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    88059 INTERSTIM II STIMULATOR, ELECTRICAL, IMPLANTABLE, FOR INCONTINENCE EZW MEDTRONIC MED REL MEDTRONIC PUERTO RICO 3058

    Patients

    Seq Age Sex Outcome Treatment
    1