BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SYNCHROMED II

    MDR report key: 2040908 · Received March 23, 2011

    Report

    Report Number
    3007566237-2011-02243
    Event Type
    Malfunction
    Date Received
    March 23, 2011
    Date of Event
    January 1, 2011
    Report Date
    March 9, 2011
    Manufacturer
    MEDTRONIC NEUROMODULATION
    Product Code
    LKK
    PMA / PMN Number
    P860004
    Removal / Correction Number
    Z-2276-2009
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4): A LOW BATTERY RESET OCCURRED IN THE ANALYSIS LAB DURING DECONTAMINATION PROCEDURE AND ALSO ONCE AGAIN WHILE THE BATTERY COMMAND TEST WAS PERFORMED. THE BATTERY FAILED THE BATTERY RESISTANCE WAVEFORM TEST WITH A HIGH RESISTANCE OF 1037 OHMS. ALL LOGS AND TELEMETRY STRIPS WERE REVIEWED AND NO LOW BATTERY RESET, ERI, OR SAFE STATE EVENTS WERE FOUND TO HAVE OCCURRED IN THE FIELD. THE DEVICE IS INCLUDED IN THE MEDICAL DEVICE SAFETY ALERT, SYNCHROMED II BATTERY PERFORMANCE, PHYSICIAN COMMUNICATION ((B)(4), 2009).

    Description of Event or Problem · 1

    THE PUMP WAS RETURNED FOR ANALYSIS BY THE HCP. IT WAS USED WITHIN A PT FOR TREATMENT. THERE WAS NO PT DEATH ASSOCIATED WITH ITS RETURN. THE REASON FOR REPLACEMENT WAS NOT REPORTED. ADD'L INFO HAS BEEN REQUESTED. A F/U REPORT WILL BE SUBMITTED IF ADD'L INFO BECOMES AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SYNCHROMED II LKK MEDTRONIC NEUROMODULATION 863720 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 19 YR EXPLANTED:| IMPLANTED:| IMPLANTED:| EXPLANTED:| CATHETER: MODEL 8575, LOT# J12142R| CATHETER: MODEL 8709, LOT# J10834R10