BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INTERSTIM II

    MDR report key: 4805276 · Received May 29, 2015

    Report

    Report Number
    3004209178-2015-09925
    Event Type
    Injury
    Date Received
    May 29, 2015
    Report Date
    May 7, 2015
    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
    VT, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    CONCOMITANT PRODUCTS: PRODUCT ID: 3037, SERIAL# (B)(4), PRODUCT TYPE: PROGRAMMER, PATIENT. PRODUCT ID: 3093-28, LOT# V003391, IMPLANTED: (B)(6) 2006, PRODUCT TYPE: LEAD. (B)(4).

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION RECEIVED REPORTED THAT THE PATIENT STILL HAD CONCERNS WITH THEIR DEVICE OR THERAPY BUT WAS RECEIVING HELP. AN APPOINTMENT FOR REPLACEMENT WAS SCHEDULED FOR (B)(6)-2015.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT WAS CONCERNED THAT THE IMPLANT WAS NOT WORKING AS IT SHOULD ANYMORE SINCE (B)(6) 2015. WHEN SHE BENT OVER OR MOVED A CERTAIN WAY, SHE FELT A STRONG-SHARP-ELECTRONIC CURRENT, WHICH SOMETIMES WENT DOWN HER LEG, BACK, ARM, OR STOMACH. THEN OUT OF THE BLUE SHE WOULD NOT FEEL ANYTHING AT ALL, REFERRING TO STIMULATION. THE PATIENT HAD ALSO BEEN STRUGGLING WITH RECURRENT URINARY TRACT INFECTIONS (UTI) AND ISSUES WITH URINARY RETENTION SINCE (B)(6) 2014. SHE HAD A PROPHYLACTIC ANTIBIOTIC AND HAD THE STIMULATION SET AT HER HIGHEST POSSIBLE LEVEL, WHICH WAS 6.35; SHE COULD NOT GO ANY HIGHER THAN THAT. IT WAS UNCLEAR IF THIS WAS DUE TO VOLTAGE RESTRICTIONS FROM THE HEALTHCARE PROVIDER (HCP) OR DUE TO OVERSTIMULATION. SHE BELIEVED THAT IT MIGHT BE TIME FOR HER TO HAVE THE IMPLANT REPLACED. HOWEVER, THE PATIENT PROGRAMMER STILL COMMUNICATED WITH THE IMPLANT AND WAS NOT SHOWING A DEAD BATTERY. NO INTERVENTIONS OR PATIENT OUTCOME WERE REPORTED, SO ADDITIONAL INFORMATION WAS REQUESTED. IF ADDITIONAL INFORMATION IS RECEIVED A SUPPLEMENTAL REPORT WILL BE SENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    349593 INTERSTIM II STIMULATOR, ELECTRICAL, IMPLANTABLE, FOR INCONTINENCE EZW MEDTRONIC MED REL MEDTRONIC PUERTO RICO 3058

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention