BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SYNCHROMED II

    MDR report key: 1901990 · Received November 12, 2010

    Report

    Report Number
    3007566237-2010-09388
    Event Type
    Injury
    Date Received
    November 12, 2010
    Date of Event
    October 26, 2010
    Report Date
    October 27, 2010
    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 THE PT HAD HER PUMP REPLACED IN 2009. SHE WENT IN FOR HER THIRD PUMP FILL (B)(6) 2010 AT THE SAME CONCENTRATION AND SAME DOSE WITH THIS NEW PUMP. BY 10:30 THAT NIGHT, SHE PRESENTED INTO THE EMERGENCY ROOM WITH SOMNOLENCE, LOW BLOOD PRESSURE AND LOW HEART RATE. THESE SYMPTOMS STARTED ABOUT AN HOUR AFTER HER REFILL. SHE WAS ADMITTED INTO ONE EMERGENCY ROOM IN THE EVENING AND THEN INTO ANOTHER THE NEXT DAY. THEY INTERROGATED HER PUMP. THEY HAD FILLED THE PUMP WITH 37.5 ML AND ASPIRATED OUT 36 ML AND THEN REFILLED HER PUMP AGAIN. THE PT DID NOT HAVE A PT MONITOR (PTM), BUT THE NURSE PRACTITIONER FELT THAT SHE PERHAPS WAS GIVEN SOME KIND OF A BOLUS AND THAT WAS HOW SHE PRESENTED WITH THE BRADYCARDIA. SHE RECOVERED FULLY WITHOUT ANY SIGNIFICANT DAMAGE. THE PUMP CONTAINED MORPHINE AT A CONCENTRATION OF 20 MG/ML AND A DOSE OF 8.5 MG/DAY. BUPIVICAINE AT A CONCENTRATION OF 20 MG/ML AND A DOSE OF 8.5 MG/DAY AND CLONIDINE AT A CONCENTRATION OF 30 MCG/ML AND A DOSE OF 148 MCG/DAY. ADDITIONAL 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 NEUROMODULATION 8637 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 58 YR Required Intervention IMPLANTED:| EXPLANTED:| CATHETER: MODEL 8709, LOT# J11443R47