BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SYNCHROMED II

    MDR report key: 2230754 · Received August 23, 2011

    Report

    Report Number
    3004209178-2011-06697
    Event Type
    Injury
    Date Received
    August 23, 2011
    Date of Event
    July 1, 2011
    Report Date
    October 11, 2011
    Manufacturer
    MDT PUERTO RICO OPERATIONS CO., JUNCOS
    Product Code
    LKK
    PMA / PMN Number
    P860004
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SC, US
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    PATIENT UNDERWENT A WITHDRAWAL AND WAS IN THE EMERGENCY ROOM ON (B)(6) 2011. IT WAS STATED THAT THE ACTUAL RESIDUAL VOLUME (ARV: 0) WAS LESS THAN THE EXPECTED RESIDUAL VOLUME (ERV: 3.7), WHICH ARE ACCEPTABLE VALUES. LOW RESERVOIR ALARM WAS DATED AS (B)(6) 2011. HCP (HEALTH CARE PROVIDER) REPORTED THAT SEVERAL TIMES IN THE PAST THE ARV WAS 3-5 MLS LOWER THAN THE ERV. HCP ALSO STATED THE "POSSIBILITY OF THE PATIENT ACCESSING THEIR OWN PUMP AND HAD A HISTORY OF SUBSTANCE ABUSE, BUT THEY WERE UNSURE OF THE CAUSE AT THIS TIME". DRUGS DELIVERED VIA THE PUMP INCLUDE HYDROMORPHONE, CLONIDINE AND BUPIVACAINE. FURTHER FOLLOW-UP ATTEMPTS WERE UNSUCCESSFUL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SYNCHROMED II LKK MDT PUERTO RICO OPERATIONS CO., JUNCOS 8637-40 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 35 YR Male Other 8731SC.| CATHETER: MODEL 8731SC, LOT# N245257003| EXPLANTED:| IMPLANTED:| IMPLANTED:| EXPLANTED:| CATHETER: MODEL 8731SC, LOT# N245257003