BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INTERSTIM II

    MDR report key: 4013054 · Received August 15, 2014

    Report

    Report Number
    3004209178-2014-15393
    Event Type
    Injury
    Date Received
    August 15, 2014
    Report Date
    July 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
    AZ, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THE PATIENT HAD A LOSS OF EFFICACY. THE OUTCOME WAS REPORTED AS ONGOING; INTERVENTION REPORTED AS REPROGRAMMING, INCREASED AMPS; ETIOLOGY REPORTED AS UNDESIRABLE CHANGE IN STIMULATION; SYMPTOMS REPORTED AS PATIENT REPORTS LACK OF EFFICACY, REPORTS SHE WAS ¿WET¿ ALL THE TIME. IT WAS FURTHER REPORTED THE PATIENT RESOLVED WITHOUT SEQUELAE ON (B)(6) 2013. ADDITIONAL INFORMATION RECEIVED REPORTED THAT THE PATIENT¿S AMPLITUDE WAS INCREASED FROM 1.8 VOLTS TO 2.5 VOLTS ON (B)(6) 2013. ADDITIONAL INFORMATION RECEIVED REPORTED THE PATIENT HAD BOTH THE LEAD AND THE NEUROSTIMULATOR EXPLANTED IN THE MIDDLE OF (B)(6) 2014. THEY RESOLVED WITHOUT SEQUELAE ON (B)(6) 2014.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    490044 INTERSTIM II STIMULATOR, ELECTRICAL, IMPLANTABLE, FOR INCONTINENCE EZW MEDTRONIC MED REL MEDTRONIC PUERTO RICO 3058

    Patients

    Seq Age Sex Outcome Treatment
    1 00075 YR Required Intervention