BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INTERSTIM

    MDR report key: 5001468 · Received August 13, 2015

    Report

    Report Number
    3007566237-2015-02276
    Event Type
    Malfunction
    Date Received
    August 13, 2015
    Report Date
    July 20, 2015
    Manufacturer
    MEDTRONIC NEUROMODULATION
    Product Code
    EZW
    PMA / PMN Number
    P970004
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TN, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    CONCOMITANT PRODUCT: PRODUCT ID: NEU_UNKNOWN_LEAD, PRODUCT TYPE: LEAD. (B)(4).

    Description of Event or Problem · 1

    IT WAS LATER REPORTED THAT THIS WAS A PERIPHERAL NERVE EVALUATION (PNE) THE SIDES WERE SWITCHED WAS THE TROUBLESHOOTING PERFORMED .THE HEALTH CARE PROVIDER STATED THAT THEIR CONTACT WITH THE PATIENT SHOWED EXCELLENT RESULT. THE HCP STATED PATIENT NEVER COMPLAINT OF THE LOW BACK WEAKNESS .

    Description of Event or Problem · 1

    THE PATIENT STATED DURING THE TRIAL THE ACTIVITY RESTRICTIONS MADE IT HARD FOR HER TO DO YARD WORK. THE PATIENT ALSO STATED THE LEAD MOVED AFTER ALMOST THE 1ST DAY AND SHE HAD SOME WEAKNESS IN HER LOW BACK AFTER THE TRIAL. NO OUTCOME WAS REPORTED REGARDING THIS EVENT. A FURTHER FOLLOW-UP IS BEING CONDUCTED TO OBTAIN THIS INFORMATION. A FOLLOW-UP REPORT WILL BE SENT IF ADDITIONAL INFORMATION BECOMES AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    532996 INTERSTIM STIMULATOR, ELECTRICAL, IMPLANTABLE, FOR INCONTINENCE EZW MEDTRONIC NEUROMODULATION 3625

    Patients

    Seq Age Sex Outcome Treatment
    1