BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SOLETRA

    MDR report key: 2446349 · Received February 10, 2012

    Report

    Report Number
    3007566237-2012-00290
    Event Type
    Injury
    Date Received
    February 10, 2012
    Date of Event
    July 7, 2010
    Report Date
    February 16, 2012
    Manufacturer
    MDT PUERTO RICO OPERATIONS CO
    Product Code
    MHY
    PMA / PMN Number
    P960009
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TN, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    IT WAS NOT POSSIBLE TO MATCH THIS EVENT OR THE REPORTED ANALYSIS WITH A PREVIOUSLY REPORTED EVENT.

    Description of Event or Problem · 1

    LITERATURE: GILL, CHANDLER E., LAURA A. ALLEN, PETER E. KONRAD, THOMAS L. DAVIS, MARK J. BLITON, STUART G. FINDER, MICHAEL G. TRAMONTANA, C. CHRIS KAO, MICHAEL S. REMPLE, COURTNEY H. BRADENHAM, AND P. DAVID CHARLES. "DEEP BRAIN STIMULATION FOR EARLY-STAGE PARKINSON'S DISEASE: AN ILLUSTRATIVE CASE." NEUROMODULATION: TECHNOLOGY AT THE NEURAL INTERFACE 14.6 (2011): 515-22. PRINT. SUMMARY: THE AUTHOR PRESENTS AN ILLUSTRATIVE CASE STUDY DESCRIBING A (B)(6) MAN WITH A TWO-YEAR HISTORY OF PARKINSON'S DISEASE (PD) WHO RECEIVED EARLY-STAGE DBS TREATMENT. THIS PATIENT WHO WAS RANDOMIZED TO DBS + ODT GROUP WAS FOLLOWED FOR A PERIOD OF TWO YEARS. THE CLINICAL OUTCOME OF EARLY DBS TREATMENT IN TANDUM WITH ANTIPARKINSONIAN MEDICATION IS DESCRIBED EXTENSIVELY IN THIS PARTICULAR STUDY. REPORTED EVENT: THE SUBJECT EXPERIENCED ONE DEVICE-RELATED ADVERSE EVENT. EIGHTEEN MONTHS AFTER IMPLANTATION THE PULSE GENERATOR BEGAN TO TURN OFF UNEXPECTEDLY, AT WHICH TIME THE SUBJECT WOULD EXPERIENCE WORSENING OF PD SYMPTOMS. THE GENERATOR WAS REPLACED AND POST-EXPLANT ANALYSIS BY THE DEVICE MAKER REVEALED FAILURE OF AN ELECTRICAL CONNECTION WITHIN THE PULSE GENERATOR. FURTHER INFORMATION IS BEING REQUESTED. A FOLLOW-UP REPORT WILL BE SENT IF ADDITIONAL INFORMATION IS RECEIVED.

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION RECEIVED INDICATES THIS MFR REPORT IS A DUPLICATE. ALL AVAILABLE INFORMATION, INCLUDING DEVICE ANALYSIS RESU LTS, HAS BEEN PREVIOUSLY REPORTED. PLEASE REFER TO MFR REPORT# 3004209178200808001.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SOLETRA STIMULATOR, ELECTRICAL, IMPLANTED, FOR PARKINSONIAN TREMOR MHY MDT PUERTO RICO OPERATIONS CO 7426

    Patients

    Seq Age Sex Outcome Treatment
    1 00056 YR Required Intervention LEAD MODEL 3389 LOT# UNKNOWN