BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SOLETRA

    MDR report key: 2120201 · Received June 6, 2011

    Report

    Report Number
    3004209178-2011-04051
    Event Type
    Injury
    Date Received
    June 6, 2011
    Date of Event
    March 28, 2011
    Report Date
    May 9, 2011
    Manufacturer
    MDT PUERTO RICO OPERATIONS CO., JUNCOS
    Product Code
    MHY
    PMA / PMN Number
    P960009
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    FOLLOWING A REPLACEMENT OF THE PT'S DEVICE FOR NORMAL BATTERY DEPLETION, IT WAS REPORTED THE PT HAD "EDEMA AROUND THE WOUND OF THE HEAD." SUBSEQUENT INFO SHOWED THE PT HAD NOT GOTTEN BETTER, BUT WAS BEING TREATED BY THEIR PHYSICIAN WITH AN UNK DRUG.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SOLETRA MHY MDT PUERTO RICO OPERATIONS CO., JUNCOS 7426 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention IMPLANTABLE NEURO STIMULATOR: MODEL 7426,| IMPLANTED:| LOT# NFW156654H| EXPLANTED: