BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SOLETRA

    MDR report key: 1060648 · Received June 13, 2008

    Report

    Report Number
    3004209178-2008-03212
    Event Type
    Injury
    Date Received
    June 13, 2008
    Date of Event
    January 1, 2008
    Report Date
    May 15, 2008
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO.
    Product Code
    MHY
    PMA / PMN Number
    P960009
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE LEAD WAS RETURNED TO THE MANUFACTURER ON 05/23/2008 FOR ANALYSIS WHICH IS NOT COMPLETE AS OF THE DATE OF THIS REPORT. A FOLLOW-UP REPORT WILL BE SENT WHEN THE ANALYSIS IS COMPLETE.

    Description of Event or Problem · 1

    THE PT EXPERIENCED SHOCKING SENSATION DOWN HER RIGHT SIDE. IMPEDANCES OF THE LEFT LEAD INDICATED AN OPEN CIRCUIT, BUT X-RAY (DATE NOT REPORTED) DID NOT SHOW ANY BREAKAGE. THE LEAD WAS REPLACED. THE IMPEDANCES AND CURRENT ON THE LEFT LEAD WERE THE FOLLOWING: SEE SCANNED TABLE. THE EXTENSION AND IMPLANTABLE PULSE GENERATOR WERE REPLACED DURING THE STAGE 2 SURGERY. ADDITIONAL INFO HAS BEEN REQUESTED, A FOLLOW-UP REPORT WILL BE SUBMITTED IF ADDITIONAL INFO BECOMES AVAILABLE.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention STIM ACCESSORY MODEL STIMLOC LOT# UNK IMPLANTED| EXPLANTED| EXPLANTED| PROGRAMMER MODEL PROGRAMMER LOT# UNK| LEAD MODEL # 3389-40| EXPLANTED| EXTENSION MODEL 7482 LOT# NHU095843V IMPLANTED