BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INTERSTIM LEAD

    MDR report key: 1023420 · Received April 2, 2008

    Report

    Report Number
    2649622-2008-01748
    Event Type
    Injury
    Date Received
    April 2, 2008
    Date of Event
    January 1, 2008
    Report Date
    March 3, 2008
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO., VILLALBA
    Product Code
    EZW
    PMA / PMN Number
    P970004
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    .

    Description of Event or Problem · 1

    THE PT REPORTED TURNING HER IPG OFF BEFORE PASSING THROUGH A SECURITY GATE IN A BANK. WHEN SHE TRIED TO TURN THE IPG ON FIVE HRS LATER, THE IPG DID NOT RESPOND. THE HCP ATTEMPTED TO TURN ON THE DEVICE USING THE PROGRAMMER AND THE IPG DIDN'T RESPOND. AN OLD PROGRAMMER WITH A NEW BATTERY WAS ALSO USED WITH THE SAME RESULTS. THE HCP REPORTED THAT THE PT EXPERIENCED BURNING AND SHOCKING SENSATION DOWN HER LOWER LEFT EXTREMITY. THE HCP BELIEVED THE INTERSTIM DEVICE HAD MOVED AND ONE OF THE LEADS WAS NOT WORKING PROPERLY. APPROX TWO WEEKS AFTER INITIAL COMPLAINT, THE PT UNDERWENT REPLACEMENT OF THE INTERSTIM DEVICE AND THE LEAD. INITIALLY THE OLD GENERATOR WAS REMOVED AND A NEW GENERATOR WAS PLACED ONTO EXISTING LEAD. HOWEVER, IT WAS STILL NOTED TO BE NONFUNCTIONING. THE OLD LEAD WAS THEN REMOVED AND THE NEW LEAD WAS PLACED. THE NEW GENERATOR WAS CONNECTED AND TESTED. IT FUNCTIONED CORRECTLY. THE HCP PLANNED TO DISCHARGE THE PT WITH A PRESCRIPTION FOR ORAL ANTIBIOTICS AND PAIN MEDICATION. SHE WAS TO RETURN TO THE UROLOGY CLINIC IN THREE TO FOUR WEEKS FOR POSTOPERATIVE EVAL. SEE ALSO MFR REPORT # 3004209178200801740.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 INTERSTIM LEAD EZW MEDTRONIC PUERTO RICO OPERATIONS CO., VILLALBA 3889 V077181

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention EXTENSION MODEL 3095 LOT# NAH035922V| IMPLANTED:| EXPLANTED:| PROGRAMMER MODEL 3037 LOT# NJD061786N| EXPLANTED:| IMPLANTED: