BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INTERSTIM II

    MDR report key: 3144545 · Received June 4, 2013

    Report

    Report Number
    3004209178-2013-08586
    Event Type
    Injury
    Date Received
    June 4, 2013
    Date of Event
    October 27, 2012
    Report Date
    May 30, 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
    NE, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    PRODUCT ID: 3889-28, LOT# V011634, IMPLANTED: (B)(6) 2006, PRODUCT TYPE: LEAD. (B)(4).

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT ¿THE DAY OF THE ACCIDENT¿ THE PATIENT WAS INCONTINENT. THE PATIENT WAS REFERRING TO A MOTOR VEHICLE ACCIDENT SHE ENDURED ON (B)(6) 2012. THE PATIENT STATED THAT EVERY DAY AFTER THE ACCIDENT SHE WAS URINATING ¿TWENTY TIMES A DAY, SEVERAL TIMES NOT MAKING IT TO THE RESTROOM.¿ A LETTER FROM A MANUFACTURER REPRESENTATIVE THAT THE PATIENT CLAIMED TO HAVE STATED THAT HER DEVICE WAS CHECKED ON (B)(6) 2012. NO SIGNS OF LEAD DAMAGE WERE FOUND AND A KIDNEY-URETER-BLADDER (KUB) X-RAY ON (B)(6) 2012 SHOWED THE DEVICE WAS IN GOOD POSITION. THE PATIENT REPORTEDLY WAS UNABLE TO FEEL STIMULATION AFTER THE ACCIDENT AND AFTER REPROGRAMMING ON (B)(6) 2012 SHE WAS ABLE TO FEEL STIMULATION BUT HAD CONTINUED SYMPTOMS. THE LETTER STATED THAT ¿THEY WERE UNABLE TO DIRECTLY SHOW THAT THE ACCIDENT CAUSED DAMAGE TO THE DEVICE.¿ IT ALSO REPORTED THAT THE BATTERY WAS AT END OF LIFE (EOL) WHICH ¿COULD ALSO BE CAUSING INTERMITTENT SENSATION.¿ THE PATIENT CLAIMED THAT THE EOL WAS NOT CORRECT BECAUSE OF A ¿BATTERY CHECK 15-30 MONTHS.¿ IT WAS NOT CLEAR WHAT THIS MEANT. THE PATIENT STATED THAT HER HEALTH CARE PROVIDER (HCP) WROTE IN HIS NOTES THAT ¿THIS WAS DUE TO THE ACCIDENT.¿ IT WAS LATER REPORTED THAT THE PERSON THE PATIENT THOUGHT WROTE THE LETTER WAS ACTUALLY A HCP. ADDITIONAL INFORMATION WAS REQUESTED, BUT WAS NOT AVAILABLE AS OF THE DATE OF THIS REPORT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    245641 INTERSTIM II STIMULATOR, ELECTRICAL, IMPLANTABLE, FOR INCONTINENCE EZW MEDTRONIC MED REL MEDTRONIC PUERTO RICO 3058

    Patients

    Seq Age Sex Outcome Treatment
    1 00047 YR Required Intervention