BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SYNCHROMED II

    MDR report key: 2143024 · Received June 23, 2011

    Report

    Report Number
    3007566237-2011-04713
    Event Type
    Injury
    Date Received
    June 23, 2011
    Date of Event
    June 16, 2011
    Report Date
    June 16, 2011
    Manufacturer
    MEDTRONIC NEUROMODULATION
    Product Code
    LKK
    PMA / PMN Number
    P860004
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THERE WAS AN ISSUE WITH THE CLINICIAN PROGRAMMER ON (B)(6) 2011. THERE WAS AN ERROR MESSAGE. THE MESSAGE OCCURRED WHILE THE MFR REP WAS UPDATING THE PUMP. THE PUMP WENT INTO STOP MODE FOR 1 MINUTE. THE REP RE-INTERROGATED THE PUMP AND THE PROGRAMMER SHOWED THE PUMP WAS IN STOP MODE, AGAIN. NO THERAPY OR MEDICAL PROBLEM WAS REPORTED. IT WAS FURTHER REPORTED THAT THE PT WAS CONVINCED THAT HER PUMP WAS NOT WORKING DUE TO WITHDRAWAL SYMPTOMS SHE EXPERIENCED. IT WAS ALSO REPORTED THAT THE PT HAD A PUMP REPLACEMENT ON (B)(6) 2011. THE CATHETER WAS NOT REPLACED. THE PT EXPERIENCED AN OVERDOSE THAT DAY. THE PHYSICIAN THOUGHT THAT THE PUMP WAS UNDERINFUSING, BUT THE RESULT WAS OVERDOSE SYMPTOMS. THE PUMP WAS DECREASED 25%, THE PT DID WELL AFTER THE DECREASE. THE CATHETER WAS ABLE TO BE ASPIRATED WITH NO DIFFICULTY. THE DRUG IN THE PUMP AT THE TIME OF THE EVENT WAS LIORESAL. ADD'L INFO HAS BEEN REQUESTED; A F/U REPORT WILL BE SUBMITTED IF ADD'L INFO BECOMES AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SYNCHROMED II LKK MEDTRONIC NEUROMODULATION 863740 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 58 YR Required Intervention EXPLANTED:| EXPLANTED:| PROGRAMMER: MODEL 8840, LOT# UNK| IMPLANTABLE INFUSION PUMP: MODEL PUMP, LOT# UNK| CATHETER: MODEL 8709, LOT# J11559R14| EXPLANTED:| IMPLANTED:| IMPLANTED:| IMPLANTED: