BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INTERSTIM II

    MDR report key: 2871556 · Received December 13, 2012

    Report

    Report Number
    3004209178-2012-11781
    Event Type
    Injury
    Date Received
    December 13, 2012
    Report Date
    November 13, 2012
    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
    TN, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    PRODUCT ID 3093-28, LOT # V098557, IMPLANTED: (B)(6) 2008, EXPLANTED: (B)(6) 2012, PRODUCT TYPE LEAD; PRODUCT ID 3037, SERIAL # (B)(4), IMPLANTED: (B)(6) 2008, PRODUCT TYPE PROGRAMMER. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THERE WAS A MALFUNCTION OF THE DEVICE. IT WAS STATED THAT THE PATIENT WAS IMPLANTED, AND HAD THE DEVICE FOR FIVE MONTHS BEFORE IT WAS REMOVED. THE REASON FOR REMOVAL WAS REPORTED AS "MALFUNCTION OF INTERSIM - FREQUENCY URGENCY." APPROXIMATELY TWO WEEKS LATER THE HEALTH CARE PROVIDER REPORTED THAT THE IMPLANTABLE NEUROSTIMULATOR (INS) ATTRIBUTED TO THE EVENT. THE ISSUE WITH THE INS WAS BATTERY DEPLETION. REPROGRAMMING WAS ATTEMPTED ON (B)(6) 2012. IMPEDANCES WERE SHOWN TO BE GREATER THAN 4,000 OHMS. THE SYSTEM WAS REPLACED ON (B)(6) 2012, AND IT WAS STATED THAT THE PATIENT RECOVERED WITHOUT SEQUELA. NO FURTHER INFORMATION WAS PROVIDED. THE USER FACILITY STATED THAT THE PATIENT WAS IMPLANTED 5 MONTHS AGO. HOWEVER, THE MANUFACTURER RECORDS INDICATE THAT THE PATIENT WAS IMPLANTED APPROXIMATELY 5 YEARS AGO ON (B)(6) 2008.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention