BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RESTORE ULTRA

    MDR report key: 5503861 · Received March 16, 2016

    Report

    Report Number
    3004209178-2016-04665
    Event Type
    Malfunction
    Date Received
    March 16, 2016
    Report Date
    July 28, 2014
    Manufacturer
    MEDTRONIC MED REL MEDTRONIC PUERTO RICO
    Product Code
    LGW
    PMA / PMN Number
    P840001
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    INFORMATION REFERENCES THE MAIN COMPONENT OF THE SYSTEM AND OTHER APPLICABLE COMPONENTS ARE: PRODUCT ID: 37761, SERIAL# (B)(4), PRODUCT TYPE: RECHARGER. PRODUCT ID: 37752 , SERIAL# (B)(4), PRODUCT TYPE: RECHARGER. PRODUCT ID: 3998, LOT# V233248 , IMPLANTED: (B)(6) 2009, PRODUCT TYPE: LEAD. PRODUCT ID: 37082-60, SERIAL# (B)(4), IMPLANTED: (B)(6) 2009, PRODUCT TYPE: EXTENSION. PRODUCT ID: 37761, SERIAL# (B)(4), PRODUCT TYPE: RECHARGER. (B)(4).

    Description of Event or Problem · 1

    THE PATIENT REPORTED THAT THEIR RECHARGER WAS NOT CHARGING. THE DESKTOP CHARGER CONNECTOR PIN WAS COMPLETELY BROKEN OFF. DUE TO THIS ISSUE THE PATIENT'S IMPLANTABLE NEUROSTIMULATOR (INS) WAS COMPLETELY EMPTY. THESE ISSUES STARTED WITHIN THE WEEK PRIOR TO THE REPORT. THE PATIENT WAS SENT A REPLACEMENT DESKTOP CHARGER. THERE WERE NO PATIENT SYMPTOMS REPORTED. THE PATIENT WAS IMPLANTED FOR OTHER CHRONIC INTRACTABLE PAIN OF THE TRUNK AND LIMBS. NO OUTCOME WAS REPORTED REGARDING THIS EVENT. FURTHER FOLLOW-UP IS BEING CONDUCTED TO OBTAIN THIS INFORMATION. IF ADDITIONAL INFORMATION IS RECEIVED, A FOLLOW-UP REPORT WILL BE SENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    160312 RESTORE ULTRA STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF LGW MEDTRONIC MED REL MEDTRONIC PUERTO RICO 37712

    Patients

    Seq Age Sex Outcome Treatment
    1 00057 YR