BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SYNCHROMED II

    MDR report key: 3170167 · Received June 14, 2013

    Report

    Report Number
    3004209178-2013-10379
    Event Type
    Injury
    Date Received
    June 14, 2013
    Date of Event
    May 16, 2013
    Report Date
    May 21, 2013
    Manufacturer
    MDT PUERTO RICO OPERATIONS CO
    Product Code
    LKK
    PMA / PMN Number
    P860004
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MO, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    CONCOMITANT PRODUCTS: PRODUCT ID 8709, LOT# J0056581R, IMPLANTED: (B)(6) 2000, PRODUCT TYPE CATHETER; PRODUCT ID 8578, SERIAL# (B)(4), IMPLANTED: (B)(6) 2010, PRODUCT TYPE ACCESSORY. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THE PATIENT WAS VISITING THE HEALTHCARE PROVIDER (HCP) ON THE DAY OF REPORT FOR A ROUTINE REFILL AND REPORTED HEARING ALARM ON (B)(6) 2013. THE PATIENT NOTED HAVING INCREASED BACK AND LEG PAIN. THE PUMP LOGS SHOWED A MOTOR STALL OCCURRED ON (B)(6) 2013 AT 2216, AND STOPPED PUMP PERIOD MAY EXCEED TUBE SET 48 HOURS LATER. NO MOTOR STALL RECOVERY HAD YET OCCURRED. THE PATIENT DENIED ANY RECENT MRI. THERE WAS NO VOLUME DISCREPANCY AT THE REFILL. THE HCP PLANNED TO PROGRAM THE PUMP TO A MINIMUM RATE AND COVER THE PATIENT WITH ORAL MEDS. THE PUMP WAS USED TO DELIVER BACLOFEN AND FENTANYL AND CLONIDINE. IT WAS LATER REPORTED THAT THE MOTOR STALL DID NOT RECOVER AND THE CAUSE WAS STILL UNKNOWN. THE PATIENT WAS SCHEDULED FOR A REPLACEMENT FOR THE WEEK OF (B)(6) 2013 AND CONTINUED TO BE MANAGED WITH MEDS. IT WAS NOTED THAT NO TROUBLE SHOOTING WAS PERFORMED. IT WAS LATER REPORTED THAT THE REVISION DATE WAS RESCHEDULED FOR (B)(6) 2013, BUT IT WAS THEN REPORTED THE PUMP WAS ACTUALLY REPLACED ON (B)(6) 2013, AS THE MOTOR STALL HAD NEVER RECOVERED. THE PATIENT EXPERIENCED LOW BACK PAIN AS A RESULT OF THE EVENT. IT WAS LATER REPORTED THE PATIENT ALSO EXPERIENCED A 9 DAY HISTORY OF INCREASED PAIN ASSOCIATED WITH THE EVENT. THE PATIENT DID NOT REQUIRE HOSPITALIZATION. ADDITIONAL INFORMATION HAS BEEN REQUESTED, BUT WAS NOT AVAILABLE AS OF THE DATE OF THIS REPORT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    271941 SYNCHROMED II PUMP, INFUSION, IMPLANTED, PROGRAMMABLE LKK MDT PUERTO RICO OPERATIONS CO 8637-40

    Patients

    Seq Age Sex Outcome Treatment
    1 00053 YR Required Intervention