BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    IISYNERGY

    MDR report key: 1180872 · Received September 23, 2008

    Report

    Report Number
    3004209178-2008-06037
    Event Type
    Malfunction
    Date Received
    September 23, 2008
    Report Date
    August 28, 2008
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO
    Product Code
    LGW
    PMA / PMN Number
    P840001
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Description of Event or Problem · 1

    THE PATIENT REPORTED NO STIMULATION SENSATION. HE ALSO REPORTED NEVER HAVING THERAPEUTIC EFFECT. THERE WAS NO KNOWN ACCIDENT OR INCIDENT RELATED TO THE EVENT. THE PATIENT'S SYMPTOMS WERE AT THE PARESTHESIA AREA. THE PATIENT HAD SEEN HIS PHYSICIAN AND THE PHYSICIAN CONFIRMED THAT THE LEAD WAS NON-FUNCTIONAL AND A REVISION WOULD BE REQUIRED. THE PATIENT WAS ENCOURAGED TO CONTINUE WORKING WITH HIS PHYSICIAN. ADDITIONAL INFO HAS BEEN REQUESTED, A FOLLOW-UP REPORT WILL BE SENT IF ADDITIONAL INFO BECOMES AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 IISYNERGY LGW MEDTRONIC PUERTO RICO OPERATIONS CO 7427 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention IMPLANTED:| EXTENSION: MODEL 7489| IMPLANTED:| EXTENSION: MODEL 7489| PROGRAMMER: MODEL 7435| EXPLANTED:| EXPLANTED:| LEAD: MODEL 3487A| EXPLANTED:| IMPLANTED:| LEAD: MODEL 3487A| IMPLANTED:| EXPLANTED: