BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SOLETRA

    MDR report key: 2210502 · Received August 10, 2011

    Report

    Report Number
    3007566237-2011-06219
    Event Type
    Injury
    Date Received
    August 10, 2011
    Date of Event
    May 20, 2011
    Report Date
    July 14, 2011
    Manufacturer
    MEDTRONIC NEUROMODULATION
    Product Code
    MHY
    PMA / PMN Number
    P960009
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A ROUTINE INS REPLACEMENT FOR AN EXPIRING BATTERY, AS INDICATED BY MILD INCREASE IN DYSTONIC TREMOR, OCCURRED. THE PATIENT DEVELOPED AN INFECTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SOLETRA MHY MEDTRONIC NEUROMODULATION 7426 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| R LEAD: MODEL 3387, LOT# UNKNOWN| IMPLANTED:| EXPLANTED: