BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INTERSTIM

    MDR report key: 2881964 · Received December 20, 2012

    Report

    Report Number
    3004209178-2012-12090
    Event Type
    Injury
    Date Received
    December 20, 2012
    Report Date
    November 29, 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
    IN, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    PRODUCT ID 3889-28, SERIAL# (B)(4), IMPLANTED: 2006 (B)(6), PRODUCT TYPE LEAD, PRODUCT ID 3095-10, SERIAL# (B)(4), IMPLANTED: 2006 (B)(6), PRODUCT TYPE EXTENSION, PRODUCT ID 3031A, SERIAL# (B)(4), IMPLANTED: 2006 (B)(6), PRODUCT TYPE PROGRAMMER, PATIENT. (B)(4).

    Description of Event or Problem · 1

    FOLLOW UP INFORMATION OBTAINED REPORTED THAT THE PATIENT WAS SCHEDULED TO HAVE THEIR INS REPLACED ON (B)(6) 2013. IT WAS ALSO NOTED THAT THE CURRENT LEAD WILL ALSO BE CHECKED AT THAT TIME AND, IF UNSATISFACTORY MOTOR RESPONSES ARE OBSERVED, THE LEAD WILL ALSO BE REPLACED. IF ADDITIONAL INFORMATION IS RECEIVED, A FOLLOW UP REPORT WILL BE SENT.

    Description of Event or Problem · 1

    HIGH IMPEDANCE READINGS OF >4000 OHMS ON ALL OF THE BIPOLAR PAIRS WERE REPORTED. THE PATIENT HAD JUST RECENTLY STARTED BEING TREATED. POOR BLADDER CONTROL AND SHOCKING AT THE IMPLANTABLE NEUROSTIMULATOR (INS) POCKET SITE ABOUT A MONTH AGO WERE ARTICULATED. IT WAS THOUGHT THAT THE PATIENT HAD STARTED HAVING ISSUES IN (B)(6) 2012 AND IT HAD BEEN DECIDED TO TURN THE INS OFF AND TO NOT USE THE THERAPY. RECENTLY THE PATIENT DECIDED THAT SHE WANTED TO TRY THERAPY AGAIN AND WANTED THE BATTERY REPLACED. BATTERY REPLACEMENT WAS PLANNED, BUT IT WAS UNCLEAR WHAT HAD CAUSED PREVIOUS ISSUES. THE PATIENT DID NOT HAVE ANY REPORTED FALLS/TRAUMA WHEN ISSUES STARTED OCCURRING. 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 STIMULATOR, ELECTRICAL, IMPLANTABLE, FOR INCONTINENCE EZW MEDTRONIC MED REL MEDTRONIC PUERTO RICO 3023

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention