BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SYNCHROMED II

    MDR report key: 2143025 · Received June 23, 2011

    Report

    Report Number
    3004209178-2011-04719
    Event Type
    Injury
    Date Received
    June 23, 2011
    Date of Event
    May 20, 2011
    Report Date
    May 31, 2011
    Manufacturer
    MDT PUERTO RICO OPERATIONS CO., JUNCOS
    Product Code
    LKK
    PMA / PMN Number
    P860004
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    VA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PT HAD THEIR PUMP REPLACED ON (B)(6) 2011 DUE TO BATTERY DEPLETION. APPROX 9 DAYS LATER, THE PT EXPERIENCED A SEIZURE. THE PUMP LOGS "LOOKED NORMAL", THEY WANTED TO RULE OUT ANY PUMP ISSUES. THERE WERE NO SYMPTOMS PRIOR TO THE PUMP REPLACEMENT. THE CAUSE OF THE SEIZURES WAS NOT DETERMINED. THE PT DID NOT HAVE ANY OTHER SYMPTOMS BESIDES THE SEIZURES AFTER THE PUMP REPLACEMENT SURGERY. THE PUMP WAS USED TO DELIVER BACLOFEN. ADD'L INFO HAS BEEN REQUESTED, A F/U REPORT WILL BE SENT IF ADD'L INFO BECOMES AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SYNCHROMED II LKK MDT PUERTO RICO OPERATIONS CO., JUNCOS 863740 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 54 YR Required Intervention IMPLANTED:| IMPLANTABLE INFUSION PUMP: MODEL 863740| LOT# NGV006280N| IMPLANTED:| CATHETER: MODEL 8709, LOT# L78417| EXPLANTED:| EXPLANTED: