BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SYNCHROMED II

    MDR report key: 3203530 · Received July 3, 2013

    Report

    Report Number
    3007566237-2013-00962
    Event Type
    Injury
    Date Received
    July 3, 2013
    Report Date
    September 5, 2012
    Manufacturer
    MEDTRONIC NEUROMODULATION
    Product Code
    LKK
    PMA / PMN Number
    P860004
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    CONCOMITANT MEDICAL PRODUCTS: PRODUCT ID 8731, SERIAL# (B)(4), IMPLANTED: (B)(6) 2005. PRODUCT TYPE: CATHETER. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PUMP WAS AT END OF LIFE AND IT WAS OUT OF MEDICINE. THE DOCTOR DISMISSED THE PATIENT BECAUSE THE PATIENT ¿HAD PROBLEM GETTING DOWN THERE.¿ IT WAS NOTED THAT THE DOCTOR WOULD ¿TAKE THE PUMP OUT IF THE PATIENT COMES BACK.¿ THE PATIENT HAD A STROKE AND SEIZURES BUT DID NOT INDICATE WHEN THIS HAPPENED. THE PATIENT WAS IN ¿SO MUCH PAIN THAT HE DID NOT REALLY WANT TO LIVE NO MORE.¿ IT WAS NOTED THAT PATIENT POSSIBLY EXPERIENCED WITHDRAWAL DUE TO THE PUMP RUNNING OUT. HE HAD BEEN IN AND OUT OF THE HOSPITAL WHERE HE WAS GIVEN SOME PAIN MEDICINE. THE PUMP WAS USED TO DELIVER AN UNKNOWN DRUG. 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
    304706 SYNCHROMED II PUMP, INFUSION, IMPLANTED, PROGRAMMABLE LKK MEDTRONIC NEUROMODULATION 863740

    Patients

    Seq Age Sex Outcome Treatment
    1 00052 YR Other