BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INTERSTIM II

    MDR report key: 4255147 · Received November 17, 2014

    Report

    Report Number
    3004209178-2014-21674
    Event Type
    Injury
    Date Received
    November 17, 2014
    Report Date
    October 24, 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
    NY, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    CONCOMITANT PRODUCTS: PRODUCT ID 3093-28, LOT # V741641, IMPLANTED: (B)(6) 2011, PRODUCT TYPE LEAD; PRODUCT ID 3037, SERIAL # (B)(4), PRODUCT TYPE PROGRAMMER, PATIENT; PRODUCT ID 3093-28, LOT # V741641, IMPLANTED: (B)(6) 2011, PRODUCT TYPE LEAD. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A FEW WEEKS AGO, THE PATIENT JOINED AN AQUA AEROBICS CLASS THROUGH THEIR LOCAL CONTINUING EDUCATION PROGRAM. THE PATIENT HAD DONE SIMILAR CLASSES IN THE PAST WITH THE INTERSTIM IMPLANTED, BUT HAD NOT DONE A CLASS SINCE THEY HAD THEIR SON LAST YEAR. DURING THE CLASS, THE PATIENT FELT A PULL AND THEN REPEATED SHOCKS AND JOLTS WHEN THEY DID A SEEMINGLY SIMPLE AEROBIC MOVE IN THE WATER. AFTER A WEEK OF MESSING WITH THE PROGRAMMING, THE PATIENT MET WITH THEIR MANUFACTURER'S REPRESENTATIVE TODAY ((B)(6) 2014) AT THEIR RECTAL SURGEON'S OFFICE. AFTER AN X-RAY, IT WAS DETERMINED THAT THE PATIENT HAD PULLED AND BENT THE WIRING FROM THE DEVICE AND WILL NEED SURGICAL REPAIR. THE INTERSTIM WAS THEN REPROGRAMMED TO OFFER SOME RELIEF UNTIL SUCH TIME OF THE SURGERY. THIS WAS FRUSTRATING TO THE PATIENT. THE PATIENT HAD ALWAYS MAINTAINED THAT EXERCISE CAN AND SHOULD BE DONE ONCE IMPLANTED. THE PATIENT WAS STRONGLY DISCOURAGED AS THE PAIN THEY FELT WITH SHIFTING WIRES AND THE RETURN OF INCONTINENCE UNTIL SURGERY LED THE PATIENT TO A PLACE WHERE THEY NEVER WANT TO MAKE THE "MISTAKE" OF WORKING OUT AGAIN. THE PATIENT WANTED TO KNOW IF THE MANUFACTURER HAD SOMEONE ON STAFF THAT THEY COULD CONSULT WITH ABOUT EFFECTIVE AND "GOOD" EXERCISES TO DO WITH THE IMPLANT? THE PATIENT KNEW THAT EXERCISE HELPED THEM LOSE WEIGHT, WHICH ALSO CAUSES THE STIMULATOR TO BE MORE EFFECTIVE. THE PATIENT WAS ABOUT 40 POUNDS OVER THE WEIGHT OF WHEN THEY HAD THE IMPLANT. THE PATIENT SAW THE CYCLE AS: INABILITY TO EXERCISE, WEIGHT GAIN, LESS EFFECTIVE DEVICE OR EXERCISE, FAILED IMPLANT, INCONTINENCE. BOTH LEAD THE PATIENT TO A PLACE THEY WOULD RATHER NOT GO. NO OUTCOME WAS REPORTED REGARDING THIS EVENT. FURTHER FOLLOW-UP IS BEING CONDUCTED TO OBTAIN THIS INFORMATION. IF ADDITIONAL INFORMATION IS RECEIVED, A FOLLOW-UP REPORT WILL BE SENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    741813 INTERSTIM II STIMULATOR, ELECTRICAL, IMPLANTABLE, FOR INCONTINENCE EZW MEDTRONIC MED REL MEDTRONIC PUERTO RICO 3058

    Patients

    Seq Age Sex Outcome Treatment
    1 00032 YR Required Intervention