BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INTERSTIM II

    MDR report key: 1926287 · Received November 11, 2010

    Report

    Report Number
    3004209178-2010-09279
    Event Type
    Malfunction
    Date Received
    November 11, 2010
    Date of Event
    January 22, 2010
    Report Date
    October 26, 2010
    Manufacturer
    MDT PUERTO RICO OPERATIONS CO., JUNCOS
    Product Code
    EZW
    PMA / PMN Number
    P960009
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NJ, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4): FINAL DEVICE ANALYSIS OF IMPLANTABLE PULSE GENERATOR (IPG) REVEALED THE FOLLOWING: AUTOMATED TEST CONSOLE: FALL, ALL ELECTRODES TO CASE. IPG WAS TESTED TWICE TO CONFIRM. LAB FUNCTIONAL TEST: THERE WAS NO OUTPUT IN UNI-POLAR MODE. IN BI-POLAR MODE, THERE WAS GOOD STABLE OUTPUT ON EVERY ELECTRODE PAIR THAT MATCHED THE PROGRAMMED SETTINGS. THERE WERE NO ISSUES WHEN PRESSING ON THE INS CAN. THE INS BATTERY STATUS ON THE 8840 PROGRAMER WAS 3.037V. CONCLUSION: IPG HYBRID ANOMALY - CAUSE UNK.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT, DURING IMPLANT, THE BATTERY SHOWED "????" FOR AN IMPEDANCE READING. TROUBLESHOOTING WAS UNSUCCESSFUL. THE BATTERY WAS REPLACED AND IMPEDANCE READINGS WERE NORMAL. THE PT RECOVERED WITHOUT SEQUELA. THE DEVICE WAS RETURNED AND NEVER USED IN A PT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 INTERSTIM II EZW MDT PUERTO RICO OPERATIONS CO., JUNCOS 3058 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 IMPLANTED:| LEAD: MODEL 3889, LOT # V386130| EXPLANTED: