BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INTERSTIM II

    MDR report key: 2890849 · Received December 31, 2012

    Report

    Report Number
    3004209178-2012-12388
    Event Type
    Injury
    Date Received
    December 31, 2012
    Report Date
    December 7, 2012
    Manufacturer
    MEDTRONIC MED REL MEDTRONIC PUERTO RICO
    Product Code
    EZW
    PMA / PMN Number
    P970004
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    CONCOMITANT MEDICAL PRODUCTS: PRODUCT ID 3889-28, LOT# V289338, IMPLANTED: (B)(6) 2010. 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 A DEVICE INTERROGATION WAS ATTEMPTED IN THE PHYSICIAN'S OFFICE ON (B)(6) 2012 UTILIZING THE CLINICIAN PROGRAMMER. THE REPORTER STATED THAT THE SYNCHRONIZATION COULD NOT BE COMPLETED, WHICH INDICATED A DEPLETED IMPLANTABLE NEUROSTIMULATOR. IT WAS REPORTED THAT THE PATIENT REQUESTED A REPLACEMENT OF THE DEVICE, WHICH WAS SCHEDULED FOR (B)(6) 2013. A FOLLOW-UP REPORT WILL BE MADE IF ADDITIONAL INFORMATION BECOMES AVAILABLE.

    Description of Event or Problem · 1

    THE PATIENT WAS DOING FINE FOLLOWING DEVICE REPLACEMENT SURGERY. IT IS UNKNOWN IF THE DEVICE WILL BE RETURNED TO THE DEVICE MANUFACTURER.

    Description of Event or Problem · 1

    IT WAS REPORTED THERE WERE TELEMETRY ISSUES WITH OR WITHOUT THE ANTENNA. IT WAS ALSO NOTED THERE WERE ANTENNA JACK PROBLEMS. IT WAS LATER REPORTED THE PATIENT WAS STILL NOT ABLE TO MAKE ADJUSTMENTS BOTH WITH OR WITHOUT THE ANTENNA ATTACHED WHILE USING THE REPLACEMENT PATIENT PROGRAMMER. IT WAS NOTED THEY BELIEVED "THE ISSUE WAS WITH THE IMPLANTABLE NEUROSTIMULATOR (INS)." THE PATIENT NOTIFIED THEIR HEALTH CARE PROVIDER (HCP) AND THE HCP SAID "THEY DO NOT KNOW ANYTHING ABOUT THE INNER WORKINGS OF THE INS." FOLLOW UP REPORTED NO DIAGNOSTIC TESTS WERE DONE BUT REPROGRAMMING WAS SCHEDULED FOR (B)(6) 2012. ADDITIONAL INFORMATION HAS BEEN REQUESTED BUT WAS NOT AVAILABLE AS OF THE DATE OF THIS REPORT; A FOLLOW-UP REPORT WILL BE SENT IF INFORMATION BECOMES AVAILABLE.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention