BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SYNCHROMED II

    MDR report key: 1760496 · Received July 15, 2010

    Report

    Report Number
    3007566237-2010-05518
    Event Type
    Injury
    Date Received
    July 15, 2010
    Report Date
    July 2, 2010
    Manufacturer
    MEDTRONIC NEUROMODULATION
    Product Code
    LKK
    PMA / PMN Number
    P860004
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A NEURO CATHETER WAS EXPLANTED AND REPLACED. IT IS UNK PER INFO RECEIVED WHY CATHETER WAS EXPLANTED OR REPLACED. DRUG DELIVERED/INTENDED TO BE DELIVERED IS UNK. PT INJURY, SYMPTOM, OR OUTCOME WAS NOT REPORTED. ADDITIONAL FOLLOW-UP WITH PT'S HCP WAS REQUESTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SYNCHROMED II LKK MEDTRONIC NEUROMODULATION 8637-20 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention EXPLANTED:| IMPLANTED:| CATHETER: MODEL 8709, LOT# J10908R49