BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SYNCHROMED II

    MDR report key: 2603908 · Received June 7, 2012

    Report

    Report Number
    3004209178-2012-04198
    Event Type
    Injury
    Date Received
    June 7, 2012
    Report Date
    May 11, 2012
    Manufacturer
    MDT PUERTO RICO OPERATIONS CO
    Product Code
    LKK
    PMA / PMN Number
    P860004
    Removal / Correction Number
    Z# 0591-2009
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Additional Manufacturer Narrative · 1

    (B)(4).

    Additional Manufacturer Narrative · 1

    CATHETER: MODEL: 8709, SERIAL# (B)(4), IMPLANTED: (B)(6) 2007, EXPLANTED: UNK. CATHETER: MODEL: 8590-1, LOT# N093707, IMPLANTED: (B)(6) 2007, EXPLANTED: UNK. (B)(4).

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION RECEIVED REPORTED THAT THE PATIENT HAD A PUMP REPLACEMENT PROCEDURE ON (B)(6) 2012. NO OTHER DETAIL WAS PROVIDED. ADDITIONAL INFORMATION HAS BEEN REQUESTED, BUT WAS NOT AVAILABLE AS OF THE DATE OF THIS REPORT.

    Description of Event or Problem · 1

    IT WAS INITIALLY REPORTED ON (B)(6) 2012 THAT PATIENT HEARD AN ALARM AND TELEMETRY WAS NOT PERFORMED. PATIENT HEARD IT SINCE THE "PAST WEEKEND", BUT WASN'T SURE IF SHE MIGHT HAVE HEARD THE ALARM PRIOR TO THAT. PATIENT'S NEXT REFILL WAS DUE ON (B)(6) 2012. SHE HAD AN MRI ON "TUES/WEDNESDAY THIS WEEK," BUT HAD NOT VISITED HER DOCTOR TO CHECK THE PUMP AFTER. PATIENT HAD MORE PAIN THAN USUAL SINCE THE PAST WEEKEND. DRUGS DELIVERED VIA THE DEVICE WERE HYDROMORPHONE AND BUPIVACAINE. AS OF THE DATE OF THIS REPORT IT WAS STATED PATIENT VISITED THE HEALTHCARE PROVIDER (HCP) DUE TO MOTOR STALL AND AUDIBLE ALARM EVERY HOUR. IT WAS CLARIFIED THAT PATIENT HAD MRI ON (B)(6) 2012 AND STARTED HAVING ANXIETY AFTER THAT. THE LOGS SHOWED MULTIPLE STALLS AND RECOVERIES. HCP ALSO INDICATED VOLUME DISCREPANCIES WITH PUMP THE LAST TIME HE SAW THE PATIENT ON (B)(6) 2012. HCP HAD ATTEMPTED TO RESTART THE PUMP; HOWEVER NOTED THAT THE STALL THAT HAD OCCURRED ON (B)(6) 2012 HAD NOT RECOVERED. ADDITIONAL INFORMATION HAS BEEN REQUESTED; A FOLLOW-UP REPORT WILL BE SENT WHEN IT BECOMES AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SYNCHROMED II PUMP, INFUSION, IMPLANTED, PROGRAMMABLE LKK MDT PUERTO RICO OPERATIONS CO 863720

    Patients

    Seq Age Sex Outcome Treatment
    1 00060 YR Required Intervention