BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SYNCHROMED II

    MDR report key: 2182321 · Received July 11, 2011

    Report

    Report Number
    3004209178-2011-05317
    Event Type
    Malfunction
    Date Received
    July 11, 2011
    Report Date
    June 17, 2011
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO., JUNCOS
    Product Code
    LKK
    PMA / PMN Number
    P860004
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MD, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THERE WERE NUMEROUS MOTOR STALLS AND WERE CONFIRMED BY THE NURSE THAT REFILLS THE PT'S PUMP. THE PT FELT THAT "HE WAS GOING THROUGH WITHDRAWAL OFF AND ON FOR SOME TIME NOW." IT WAS STATED THAT THE PUMP STALLED ON (B)(6) 2011 FOR 2 DAYS. DURING THAT TIME THE PT "SLEPT FOR 30 HRS AND LATER WOKE UP VOMITING, WAS COLD AND VERY WEAK." THE CURRENT MANAGING PHYSICIAN DID NOT DO IMPLANTS. PT WAS ADMITTED ON (B)(6) 2011 BUT THEN DISCHARGED ON (B)(6) 2011 AND WERE TOLD "THEY DID NOT ACCEPT NEW PTS." ANOTHER HOSP SAID REPLACING THE PUMP WAS NOT AN EMERGENCY AND THE DOCTOR WAS CALLED TWICE AND NOTHING THEREAFTER. THE DRUGS INFUSED VIA THE PUMP WERE MORPHINE, CLONIDINE AND BUPIVACAINE (MARCAINE), STATUS CURRENT. ADD'L INFO 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
    1 SYNCHROMED II LKK MEDTRONIC PUERTO RICO OPERATIONS CO., JUNCOS 863740 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 CATHETER: MODEL 8709SC, LOT# N072613018| EXPLANTED:| IMPLANTED: