BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SYNCHROMED II

    MDR report key: 2130529 · Received June 14, 2011

    Report

    Report Number
    3004209178-2011-04386
    Event Type
    Injury
    Date Received
    June 14, 2011
    Date of Event
    May 1, 2011
    Report Date
    May 17, 2011
    Manufacturer
    MDT PUERTO RICO OPERATIONS CO., JUNCOS
    Product Code
    LKK
    PMA / PMN Number
    P860004
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE DEVICE HAS BEEN RETURNED TO THE MFR FOR ANALYSIS. A F/U REPORT WILL BE SENT WHEN THE ANALYSIS IS COMPLETE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A CRITICAL ALARM HAD OCCURRED DUE TO A MOTOR STALL. THE LOGS SHOWED MULTIPLE MOTOR STALLS AND RECOVERIES. ON (B)(6) 2011, THE PUMP MOTOR HAD STALLED AND AS OF (B)(6) 2011, THE STALL HAD NOT RECOVERED. IT WAS BELIEVED THAT THERE HAS NOT BEEN ANY ELECTROMAGNETIC INTERFERENCE. THE PT'S PUMP HAD BEEN PROGRAMMED TO DELIVER LIORESAL 2000 MCG/ML. THE PT EXPERIENCED WITHDRAWAL SYMPTOMS WITH INCREASED SPASTICITY. THE PT WAS USING ORAL BACLOFEN AS ADJUNCT THERAPY. THE PUMP WAS REPLACED ON (B)(6) 2011. ON THAT DATE, THE LOGS REVEALED THAT THE PUMP HAD RECOVERED SINCE THE STALL ON (B)(6) 2001, BUT MULTIPLE OTHER STALLS HAD OCCURRED. THE PUMP HAD A LOW BATTERY RESET AND THE PUMP WAS IN SAFE STATE. PER THE RPTR, THE PT HAD RECOVERED WITHOUT SEQUELA AND WAS DOING WELL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SYNCHROMED II LKK MDT PUERTO RICO OPERATIONS CO., JUNCOS 863720 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 13 YR Required Intervention EXPLANTED:| IMPLANTED:| CATHETER: MODEL 8709, LOT# N100824021