BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RESTORE PRIME ADVANCED

    MDR report key: 1963499 · Received December 20, 2010

    Report

    Report Number
    3007566237-2010-10585
    Event Type
    Malfunction
    Date Received
    December 20, 2010
    Date of Event
    December 3, 2010
    Report Date
    December 3, 2010
    Manufacturer
    MEDTRONIC NEUROMODULATION
    Product Code
    LGW
    PMA / PMN Number
    P840001
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). ANALYSIS RESULTS WERE NOT AVAILABLE AT THE TIME OF THIS REPORT. A FOLLOW-UP REPORT WILL BE SENT WHEN ANALYSIS IS COMPLETED.

    Description of Event or Problem · 1

    INFO RECEIVED STATES THE SURGEON HAD DIFFICULTY POSITIONING THE LEAD. DURING INTRA-OPERATIVE TESTING, THE PT WAS UNABLE TO FEEL STIMULATION WITH THE LEAD. THE LEAD WAS REPLACED AND NO PT INJURY WAS REPORTED.

    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 58 YR IMPLANTED:| EXPLANTED:| EXPLANTED:| LEAD: MODEL 3888, LOT# UNK| IMPLANTED:| EXPLANTED:| IMPLANTED:| EXPLANTED:| EXPLANTED:| LEAD: MODEL 3888, LOT# V517760| EXPLANTED:| LEAD: MODEL 3888, LOT# V517760| IMPLANTED:| EXTENSION: MODEL 37082, LOT# NKB008494V| LEAD: MODEL 3888, LOT# V541580| IMPLANTED:| LEAD: MODEL 3778, LOT# V5532340432| PROGRAMMER: MODEL 37743, LOT# NKE156128N| IMPLANTED: