BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INTERSTIM II

    MDR report key: 3902664 · Received June 30, 2014

    Report

    Report Number
    3004209178-2014-12275
    Event Type
    Injury
    Date Received
    June 30, 2014
    Report Date
    June 9, 2014
    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

    CONCOMITANT MEDICAL PRODUCTS: PRODUCT ID 3889-28, LOT# VA0C6GQ, IMPLANTED: (B)(6) 2013, EXPLANTED: (B)(6) 2014, PRODUCT TYPE: LEAD; PRODUCT ID 3889-28, LOT# VA0C6GQ, IMPLANTED: (B)(6) 2013, EXPLANTED: (B)(6) 2014; PRODUCT TYPE: LEAD; PRODUCT ID 3037, SERIAL# (B)(4), PRODUCT TYPE: PROGRAMMER, PATIENT. (B)(4).

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    THE REASON SHE WAS RECEIVED A NEW NEUROSTIMULATOR (INS) AND LEAD WAS DUE TO LACK OF THERAPY AND HIGH IMPEDANCES. IT WAS INDICATED THAT THE PATIENT FELL BUT THE TIMELINE BETWEEN THE FALL AND THE THERAPY ISSUES WAS UNCLEAR. IT WAS INDICATED THAT THEY HAD AN X-RAY TAKEN "A FEW WEEKS AGO" PRIOR TO THIS CALL, SHOWED THAT THE LEAD HAD MOVED. IT WAS INDICATED THAT THEY HAD BEEN TRYING TO REPROGRAM THE PATIENT FOR "A WHILE."IT WAS INDICATED THAT WHEN THE PATIENT WAS OPENED UP ON THE DAY OF THE REPORT, THE NEUROSTIMULATOR (INS) HEADER BLOCK HAD FLUID IN IT. A FOLLOW-UP REPORT WILL BE SENT IF ADDITIONAL INFORMATION BECOMES AVAILABLE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT LATER THAT PATIENT HAD BRUISES AND BUMPS ALL OVER HER BODY. THE PATIENT'S SOCKS WERE REMOVED IN THE OPERATION ROOM AND HER LEGS WERE COVERED IN BRUISES. IT WAS NOTED THAT IT WAS A COMMON OCCURRENCE FOR THIS PATIENT, WHICH MADE IT DIFFICULT TO KNOW WHAT WAS SIGNIFICANT AND WHAT WAS NOT. IT WAS NOTED THAT THE PATIENT HAD A DIFFICULT TIME RECALLING EVENTS. IT WAS NOTED THAT CALLER INITIALLY FELT THE PATIENT HAD GOOD THERAPY; HOWEVER, IN THE HEALTH CARE PROVIDER'S OPINION, THE PATIENT DID NOT HAVE RESULTS FROM THE BEGINNING. THE CALLER WAS UNABLE TO DETERMINE WHETHER OR NOT THE PATIENT'S FALL WAS DEVICE RELATED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    380123 INTERSTIM II STIMULATOR, ELECTRICAL, IMPLANTABLE, FOR INCONTINENCE EZW MEDTRONIC MED REL MEDTRONIC PUERTO RICO 3058

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention