BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SYNCHROMED II

    MDR report key: 1940375 · Received December 20, 2010

    Report

    Report Number
    3004209178-2010-10610
    Event Type
    Injury
    Date Received
    December 20, 2010
    Date of Event
    November 25, 2010
    Report Date
    December 9, 2010
    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
    MN, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    THE PT EXPERIENCED OVERDOSE-TYPE SYMPTOMS: THE PT WAS IN THE ER UNRESPONSIVE. THE ER PHYSICIAN AND "HOSPITALIST" WANTED THE PUMP DOSAGE REDUCED BY 10%. IT WAS NOTED THAT THE PUMP MANAGING PHYSICIAN DID NOT HAVE CREDENTIALS AT THE HOSPITAL, SO THERE WAS VERY LITTLE FEEDBACK; "ONLY P.A. INVOLVED." THE PUMP DOSAGE WAS DECREASED BY 10% ON BOTH DRUGS; THE PUMP WAS USED TO DELIVER FENTANYL AND BACLOFEN. THE "HOSPITALIST SEEMED TO THINK" THE PT HAD A STROKE AND THE PT WAS ADMITTED. THE PUMP PRINTOUTS WERE DELIVERED TO THE PUMP MANAGING PHYSICIAN'S OFFICE THE NEXT BUSINESS DAY. ADDITIONAL INFO HAS BEEN REQUESTED. A FOLLOW-UP REPORT WILL BE SENT IF ADDITIONAL INFO BECOMES AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SYNCHROMED II LKK MDT PUERTO RICO OPERATIONS CO., JUNCOS 8637-20 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 46 YR Hospitalization EXPLANTED:| EXPLANTED:| IMPLANTED:| CATHETER: MODEL 8709, LOT #: N236533008| PROGRAMMER: MODEL 8835, LOT #: NPG014815N| IMPLANTED: