BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RESTORE PRIME ADVANCED

    MDR report key: 2219645 · Received August 11, 2011

    Report

    Report Number
    3007566237-2011-06253
    Event Type
    Malfunction
    Date Received
    August 11, 2011
    Date of Event
    July 18, 2011
    Report Date
    July 18, 2011
    Manufacturer
    MEDTRONIC NEUROMODULATION
    Product Code
    LGW
    PMA / PMN Number
    P840001
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A LOSS OF THERAPEUTIC EFFECT OCCURRED FOLLOWING AN IMPLANTABLE NEUROSTIMULATOR REPLACEMENT. ALSO REPORTED WAS THAT READINGS OF > 1000 OHMS WERE MEASURED. IMPEDANCES WERE NOT TAKEN AT THE TIME OF THE IMPLANT. THE PT COULD NOT FEEL STIMULATION ON 0-3 BUT DID FEEL STIMULATION ON 4-7. IMPEDANCES WERE HIGH ON 0-3 AND NORMAL ON 4-7. IMPEDANCES 01- 2899, 02- 2899, 03- 4610, 1-2- 2604, 1-3- 2119, 2-3- 2397, 4-5- 83, 4-6- 929, 4-7- 955, 5-6- 671, 5-7- 868, 6-7- 787. A POTENTIAL NEED FOR A SURGICAL REVISION WAS NOTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 RESTORE PRIME ADVANCED LGW MEDTRONIC NEUROMODULATION 37702 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 61 YR EXPLANTED:| EXPLANTED:| EXPLANTED:| IMPLANTED:| LEAD: MODEL 3487A, LOT #J0437051V| EXTENSION: MODEL 7489, LOT #NHU066880V| LEAD: MODEL 3487A, LOT #J0437051V| IMPLANTED:| IMPLANTED:| EXTENSION: MODEL 7489, LOT#NHU066879V| IMPLANTED:| EXPLANTED: