BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RESTORE

    MDR report key: 5664593 · Received May 18, 2016

    Report

    Report Number
    3004209178-2016-09784
    Event Type
    Malfunction
    Date Received
    May 18, 2016
    Report Date
    May 26, 2016
    Manufacturer
    MEDTRONIC MED REL MEDTRONIC PUERTO RICO
    Product Code
    LGW
    PMA / PMN Number
    P840001
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    A GOOD FAITH EFFORT WILL BE MADE TO OBTAIN THE APPLICABLE INFORMATION RELEVANT TO THE REPORT. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Additional Manufacturer Narrative · 1

    OTHER APPLICABLE COMPONENTS ARE: PRODUCT ID: 377860, LOT# V011955, IMPLANTED: (B)(6) 2006, PRODUCT TYPE: LEAD. PRODUCT ID: 377860, LOT# V011672, IMPLANTED: (B)(6) 2006, PRODUCT TYPE: LEAD. (B)(4). IT WAS REPORTED THERE WAS AN ISSUE WITH ONE LEAD, BUT IT IS UNKNOWN WHICH LEAD WAS BEING REFERRED TO.

    Additional Manufacturer Narrative · 1

    IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION RECEIVED FROM A HEALTHCARE PROVIDER (HCP) REPORTED THE HCP HAD NOT HAD CONTACT WITH THE PATIENT SINCE (B)(6) 2012.

    Description of Event or Problem · 1

    INFORMATION WAS RECEIVED FROM A CONSUMER REGARDING A PATIENT WHO WAS IMPLANTED WITH A NEUROSTIMULATOR FOR COMPLEX REGIONAL PAIN SYNDROME TYPE I. IT WAS REPORTED THE PATIENT SAW THE MANUFACTURER'S REPRESENTATIVE (REP) AT THE HEALTHCARE PROVIDER'S (HCP) OFFICE AND THEY DETERMINED THAT ONE OF THE LEADS WAS NOT WORKING PROPERLY. THE PATIENT NOTED THAT THE ONE LEAD HAD NOT BEEN WORKING PROPERLY FOR WAY OVER A YEAR. THE PATIENT DID NOT REMEMBER WHEN THE REP WAS NOTIFIED, BUT NOTED THAT IT "MAY HAVE BEEN LAST YEAR" AND AT THAT APPOINTMENT THE REP DETERMINED THE LEAD WAS NOT WORKING PROPERLY. NO PATIENT SYMPTOMS WERE REPORTED REGARDING THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    318246 RESTORE STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF LGW MEDTRONIC MED REL MEDTRONIC PUERTO RICO 37711

    Patients

    Seq Age Sex Outcome Treatment
    1