BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SYNCHROMED II

    MDR report key: 2231094 · Received August 26, 2011

    Report

    Report Number
    3004209178-2011-06937
    Event Type
    Injury
    Date Received
    August 26, 2011
    Date of Event
    July 1, 2011
    Report Date
    August 8, 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
    NV, US
    Reporter Occupation
    NURSE
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    THE PT EXPERIENCED UNDERDOSE SYMPTOMS: SWEATING (DIAPHORESIS) AND CHILLS. THE SYMPTOMS OCCURRED "FOR (B)(6)" (B)(6) PRIOR TO THE DATE OF THIS REPORT. A (B)(6) WAS ALSO NOTED: THE ACTUAL VOLUME WAS 0 MLS, THE EXPECTED VOLUME WAS 3.6 MLS. THE PT DID USE HOT TUBS BUT MADE SURE TO STAY OUT OF 102 DEGREE TEMPERATURES. THE PT ALSO USED A BONE GROWTH STIMULATOR BUT IT DID NOT HAVE A HEAT FUNCTION. IT WAS LATER REPORTED THAT A PUMP REFILL OCCURRED (B)(6) 2011. THE PT EXPERIENCED THE OVERDOSE SYMPTOM OF SEDATION FOLLOWING THE REFILL. THE PT WAS ADMITTED TO THE E.R. AND HOSPITAL ON (B)(6) 2011. THE PT WAS GIVEN NARCAN AND THE PUMP WAS PROGRAMMED FROM 8.6 MG/DAY TO 2 MG/DAY. THE PT WAS OBSERVED FOR 12 HOURS AND DISCHARGED FROM THE HOSPITAL ON (B)(6) 2011. AS OF (B)(6) 2011, THE PT WAS DOING FINE. THE PT'S PUMP CONTAINED COMPOUNDED BACLOFEN, IN ADDITION TO MORPHINE AND CLONIDINE.

    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 45 YR Male Hospitalization| O| R ACCESSORY: MODEL 8590-1, LOT# N066077| CATHETER: MODEL 8731, LOT# N062610020| EXPLANTED:| EXPLANTED:| EXPLANTED:| IMPLANTED:| IMPLANTED:| IMPLANTED:| PROGRAMMER: MODEL 8832, LOT# NJG002706N| EXPLANTED:| ACCESSORY: MODEL 8590-1, LOT# N066077| CATHETER: MODEL 8731, LOT# N062610020| IMPLANTED:| EXPLANTED:| IMPLANTED:| IMPLANTED:| EXPLANTED:| PROGRAMMER: MODEL 8832, LOT# NJG002706N