BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SYNCHROMED II

    MDR report key: 3252943 · Received July 29, 2013

    Report

    Report Number
    3004209178-2013-12446
    Event Type
    Injury
    Date Received
    July 29, 2013
    Report Date
    July 5, 2013
    Manufacturer
    MDT PUERTO RICO OPERATIONS CO
    Product Code
    LKK
    PMA / PMN Number
    P860004
    Removal / Correction Number
    Z-0497-2013
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    ANALYSIS OF THE PUMP REVEALED A STALL DUE TO THE SHAFT-BEARING OF THE MOTOR GEAR TRAIN AS WELL AS CORROSION, WEAR, AND LUBRICATION OF THE GEAR TRAIN.

    Additional Manufacturer Narrative · 1

    PRODUCT ID: 8575, LOT# N165152, IMPLANTED: (B)(6) 2009, PRODUCT TYPE: ACCESSORY. PRODUCT ID: 8835, SERIAL# (B)(4), PRODUCT TYPE: PROGRAMMER. PATIENT PRODUCT ID: 8709, SERIAL# (B)(4), IMPLANTED: (B)(6) 2005, PRODUCT TYPE: CATHETER. (B)(4).

    Additional Manufacturer Narrative · 1

    IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Description of Event or Problem · 1

    A HEALTHCARE PROVIDER REPORTED AN ERROR CODE 8476 ON THE PTM PROGRAMMER, INDICATING THAT A MOTOR STALL OCCURRED. THE PATIENT¿S LEGS WERE FEELING TINGLY. THE PATIENT DID NOT HAVE AN MRI. THE MEDICATIONS USED WITHIN THE SYSTEM WERE BUPIVACAINE AND MORPHINE. A REPRESENTATIVE LATER REPORTED THAT THE PUMP HAD MULTIPLE MOTOR STALLS OVER A PERIOD OF SEVERAL DAYS. THE PATIENT WENT INTO WITHDRAWAL, AND THEIR DOCTOR SET THE PUMP TO MINIMUM RATE AND GAVE THE PATIENT ORAL MEDICATIONS. THE PUMP WAS REPLACED ON (B)(6) 2013. THE PATIENT¿S SYMPTOMS INCLUDED UNDERDOSE SYMPTOMS INCLUDING FLU-LIKE SYMPTOMS, AGITATION, AND NAUSEA, AND LESS THAN 50% THERAPY RELIEF. THE LOGS LATER CONFIRMED THAT THE STOPPED PUMP PERIOD MAY EXCEED THE TUBE SET ON (B)(6) 2013.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    353593 SYNCHROMED II PUMP, INFUSION, IMPLANTED, PROGRAMMABLE LKK MDT PUERTO RICO OPERATIONS CO 8637-40

    Patients

    Seq Age Sex Outcome Treatment
    1 00059 YR Required Intervention