BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INTERSTIM II

    MDR report key: 3250581 · Received July 26, 2013

    Report

    Report Number
    3004209178-2013-12371
    Event Type
    Malfunction
    Date Received
    July 26, 2013
    Report Date
    July 2, 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
    TX, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    CONCOMITANT MEDICAL PRODUCTS: PRODUCT ID: 3037, SERIAL# (B)(4), PRODUCT TYPE: PROGRAMMER, PATIENT. PRODUCT ID: 3 093-33, LOT# V888674, IMPLANTED: (B)(6) 2012, PRODUCT TYPE: LEAD. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THE PATIENT HAD A SHOCKING OR JOLTING SENSATION. THE REPORTER STATED THEY HAD BEEN GOING TO THE BATHROOM AND HAD PROBLEMS WITH A DISC IN THEIR BACK. IT WAS NOTED THE PATIENT WAS GIVEN A TRANSCUTANEOUS ELECTRICAL NERVE STIMULATOR (TENS) UNIT BY THEIR HEALTHCARE PROFESSIONAL. IT WAS NOTED THE PATIENT USED THE TENS ONCE A DAY BETWEEN (B)(6) 2013. THE REPORTER STATED THAT WHEN SHE USED THE TENS SHE FELT AN ELECTRICAL SHOCK ON HER LIP, FINGER, RIGHT AND LEFT HAND, AND SOMETIMES THE LEG. IT WAS NOTED THE PATIENT USED THE TENS ON THEIR SHOULDERS AND NOT ON THEIR SPINE BECAUSE ¿IF FELT WEIRD.¿ THE REPORTER STATED ¿SHE STILL FEELS LIKE THAT BUT NOT AS STRONG.¿ IT WAS NOTED THE PATIENT FELT THE ELECTRICAL SHOCK THE SECOND TIME SHE USED THE TENS UNIT. ADDITIONAL INFORMATION RECEIVED REPORTED THE CAUSE OF THE EVENT WAS THE USE OF TENS. IT WAS NOTED THE PATIENT WAS REPROGRAMMED ON (B)(6) 2013 TO CHANGE THE LEAD AND REPROGRAM THE VOLTAGE. THE REPORTER STATED THAT ONCE THE PATIENT STOPPED USING TENS, THE INS WAS REPROGRAMMED AND WAS WORKING WELL. IT WAS REPORTED THAT THE PATIENT HAD NOT REPORTED ANY MORE SHOCKING OR JOLTING SENSATIONS. IT WAS NOTED THE PATIENT WAS NOT HOSPITALIZED AND RECOVERED WITHOUT SEQUELA. 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
    350364 INTERSTIM II STIMULATOR, ELECTRICAL, IMPLANTABLE, FOR INCONTINENCE EZW MEDTRONIC MED REL MEDTRONIC PUERTO RICO 3058

    Patients

    Seq Age Sex Outcome Treatment
    1 00065 YR