BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SYNCHROMED

    MDR report key: 4844666 · Received June 15, 2015

    Report

    Report Number
    3007566237-2015-01654
    Event Type
    Injury
    Date Received
    June 15, 2015
    Report Date
    May 26, 2015
    Manufacturer
    MEDTRONIC NEUROMODULATION
    Product Code
    LKK
    PMA / PMN Number
    P860004
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    CONCOMITANT MEDICAL PRODUCT: PRODUCT ID: 8703W, LOT# L41567, IMPLANTED: 1997-(B)(6), PRODUCT TYPE: CATHETER. (B)(4).

    Description of Event or Problem · 1

    THE PATIENT REPORTED THAT THEY WERE OVERDOSED ON THE PUMP. THE PATIENT WAS NOT SURE IF THE DEVICE MALFUNCTIONED OR IF THE HEALTHCARE PROVIDER HAD PRESCRIBED TOO MUCH MEDICATION. THE PATIENT WAS LEFT IN A VEGETATIVE STATED FOR 3 MONTHS DUE TO THE INCIDENT AND HAS LOSS HEARING IN ONE EAR. THE PUMP HAS SINCE BEEN REMOVED. ADDITIONAL INFORMATION LATER RECEIVED REPORTED THAT PER THE IMPLANTING HEALTHCARE PROVIDER THEY TREATED THE PATIENT FOR THE REMOVAL OF THEIR PUMP IN 2004 AND COMPLETED THE PATIENT¿S POST-OP CARE AS WELL. THE NURSE REVIEWED ALL OF THE CLINIC AND HOSPITAL NOTES FROM THAT SURGERY AND NO COMPLICATIONS WERE NOTED. THE HCP HAD ALSO OPERATED ON THE PATIENT IN 1998 AND 2006 AND PER THE NURSE NO COMPLICATIONS NOTED FOR THOSE SURGERIES EITHER. THE NURSE ALSO STATED THAT THE DOCTOR IS ¿A SPINE DOCTOR¿, SO EACH OF THE PATIENT¿S SURGERIES WERE RELATED TO HER BACK ISSUES AND NOT THE DEVICES. THE DOCTOR REMOVED THE PUMP BECAUSE THE PATIENT WAS NOT USING IT AND IT WAS IN THE WAY OF THE SURGERY THAT HE WAS DOING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    387460 SYNCHROMED PUMP, INFUSION, IMPLANTED, PROGRAMMABLE LKK MEDTRONIC NEUROMODULATION 861718

    Patients

    Seq Age Sex Outcome Treatment
    1 00053 YR Required Intervention| S