BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SYNCHROMED II

    MDR report key: 2052518 · Received April 11, 2011

    Report

    Report Number
    3007566237-2011-02738
    Event Type
    Injury
    Date Received
    April 11, 2011
    Date of Event
    March 27, 2011
    Report Date
    March 28, 2011
    Manufacturer
    MEDTRONIC NEUROMODULATION
    Product Code
    LKK
    PMA / PMN Number
    P860004
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A CRITICAL ALARM REGARDING A PUMP MOTOR STALL OCCURRED; AND THEY WERE UNABLE TO INTERROGATE THE DEVICE. A PRINTOUT WAS NOTED TO HAVE INDICATED THE PUMP STALL, BUT DID NOT SHOW A SPONTANEOUS RESTART COMMAND. PER THE PUMP LOGS, A MOTOR STALL OCCURRED ON (B)(6) 2011. THE PHYSICIAN HAD INDICATED THAT HE DID NOT TRUST THE DEVICE, SO HE WANTED IT REPLACED. THE ELECTIVE REPLACEMENT INDICATOR (ERI) SHOWED 25 MONTHS. THE PT WAS TREATED PROPHYLACTICALLY WITH ORAL MEDICATION TO AVOID HAVING THE PT EXPERIENCE WITHDRAWAL. WITHDRAWAL WAS NOTED AS NOT HAVING HAD OCCURRED. NEITHER A DYE NOR ROTOR STUDY WAS PERFORMED. THE EXPLANTED PUMP WAS PLANNED TO BE SENT TO THE MFR FOR ANALYSIS. FOLLOWING THE PUMP REPLACEMENT PROCEDURE, THE PT HAD RECOVERED WITHOUT SEQUELA. THE MEDICATION BEING ADMINISTERED VIA THE PUMP WAS DILAUDID (10.0 MG/ML AT 8.991 MG/DAY). ADDITIONAL INFO WILL BE PROVIDED IN A F/U REPORT, AS IT BECOMES AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SYNCHROMED II LKK MEDTRONIC NEUROMODULATION 863740 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 63 YR Required Intervention EXPLANTED:| IMPLANTED:| CATHETER: MODEL 8709, LOT# UNK