BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SYNCHROMED EL

    MDR report key: 2962247 · Received February 14, 2013

    Report

    Report Number
    6000030-2013-00028
    Event Type
    Injury
    Date Received
    February 14, 2013
    Report Date
    January 16, 2013
    Manufacturer
    RICE CREEK MFG
    Product Code
    LKK
    PMA / PMN Number
    P860004
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    PRODUCT ID 8709, LOT# J11277R26, IMPLANTED: 2002-(B)(6), PRODUCT TYPE CATHETER. (B)(4).

    Additional Manufacturer Narrative · 1

    PRODUCT ID 8709, LOT # J11277R26, IMPLANTED: (B)(6) 2002, EXPLANTED: UNK; PRODUCT TYPE CATHETER.

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION RECEIVED REPORTED THAT THE PATIENT HAD A CATHETER REPLACED IN 2002 AND 2 PUMP REPLACEMENTS IN 2003. ONE OCCURRED IN (B)(6) AND THE OTHER ONE IN (B)(6). THE CLINIC DID NOT HAVE ACCESS TO THE REASON FOR THE REPLACEMENTS. REFER TO MANUFACTURER REPORT #6000030-2013-00027 FOR DETAILS INVOLVING THE PATIENT'S FIRST PUMP.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT'S PUMP "QUIT WORKING". THE PATIENT WENT INTO SEVERE WITHDRAWALS AND WAS NEARLY "KILLED". IT WAS NOTED THAT THE BATTERY HAD DIED ON ONE OF THE PATIENT'S PUMPS, BUT IT WAS UNCLEAR WHICH ONE. REFER TO MANUFACTURER REPORT #6000030-2013-00027 FOR DETAILS INVOLVING THE PATIENT'S FIRST PUMP. THE DRUG USED IN THIS SYSTEM WAS DEMEROL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    64484 SYNCHROMED EL PUMP, INFUSION, IMPLANTED, PROGRAMMABLE LKK RICE CREEK MFG 8627L18

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention