BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SOLETRA

    MDR report key: 1071299 · Received July 8, 2008

    Report

    Report Number
    3004209178-2008-03852
    Event Type
    Injury
    Date Received
    July 8, 2008
    Date of Event
    May 1, 2008
    Report Date
    June 23, 2008
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO.
    Product Code
    MHY
    PMA / PMN Number
    P960009
    Removal / Correction Number
    Z-0694-2008
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE HAS BEEN RETURNED TO THE MFR 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 WAS UNABLE TO ADJUST HIS DEEP BRAIN STIMULATION. STATUS LIGHTS ON THE THERAPY CONTROLLER WERE ASSESSED. THE GREEN 9 VOLT THERAPY CONTROLLER LIGHT WAS ON. THE GREEN NEUROSTIMULATOR BATTERY LIGHT WAS OFF ON THE LEFT-SIDE. THE PT COULD NOT TURN ON THE LEFT SIDED NEUROSTIMULATOR WITH THE PT PROGRAMMER. THE PT PROGRAMMER SHOWED STIMULATION ON THE RIGHT SIDE. THE GREEN NEUROSTIMULATOR BATTERY LIGHT WAS LIT ON THE RIGHT SIDE. THE PT EXPERIENCED TREMORS AND BRADYKINESIA. AN X-RAY TAKEN IN 08 WAS WITHIN NORMAL LIMITS. THE RIGHT SIDED DEVICE WAS REPROGRAMMED. THE LEFT-SIDE DEVICE WAS OFF PERMANENTLY. THE IMPLANTABLE NEUROSTIMULATORS WERE REPLACED. BOND WIRE LIFT WAS SUSPECTED BY THE HCP WITH ONE DEVICE. THE HCP REPORTED THE OUTCOME AS 'NO INJURY'. PLEASE REFERENCE MFG REPORT # 3004209178200803233.

    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 IMPLANTED| IMPLANTED| IMPLANTED| EXTENSION MODEL 7482 LOT# NHU074583V| IMPLANTABLE NEUROSTIMULATOR MODEL# 7426| LEAD MODEL LEADMVD LOT# UNK| EXPLANTED| LEAD MODEL 3389 LOT# J0444009V| IMPLANTED| EXPLANTED| IMPLANTED| PROGRAMMER MODEL PROGRAMMER LOT # UNK| EXPLANTED| EXTENSION MODEL 7482 LOT# NHU067656V| EXPLANTED| EXPLANTED