BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SOLETRA

    MDR report key: 1892377 · Received November 3, 2010

    Report

    Report Number
    3004209178-2010-08799
    Event Type
    Injury
    Date Received
    November 3, 2010
    Date of Event
    October 1, 2010
    Report Date
    October 11, 2010
    Manufacturer
    MDT PUERTO RICO OPERATIONS CO., JUNCOS
    Product Code
    MHY
    PMA / PMN Number
    P960009
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    THE RIGHT SIDE OF THE PATIENT'S BILATERAL IMPLANTABLE NEUROSTIMULATOR SYSTEM BECAME INFECTED AND HAD TO BE EXPLANTED. THE LEFT SIDE "IS CURRENTLY MEASURING 2.97 EOL AT 180 PW, 5 V AND 185 RATE" WITH IMPEDANCE OF "710 AND 0-, 1- AND 2+." THE PULSE WIDTH WAS DECREASED. ADDITIONAL INFORMATION HAS BEEN REQUESTED, A FOLLOW-UP REPORT WILL BE SENT IF ADDITIONAL INFORMATION BECOMES AVAILABLE.

    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 68 YR Required Intervention EXPLANTED:| IMPLANTABLE NEURO STIMULATOR: MODEL 7426| EXTENSION: MODEL 7482, LOT# NHU198529V| IMPLANTED:| LEAD: MODEL 3387S, LOT# V287456| IMPLANTED:| EXPLANTED:| EXTENSION: MODEL 7482A, LOT# NHU201903V| IMPLANTED:| EXPLANTED:| LEAD: MODEL 3387S, LOT# V331504| LOT# NFW158429H| IMPLANTED:| IMPLANTED:| EXPLANTED:| EXPLANTED: