BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RESTORE PRIME ADVANCED

    MDR report key: 2092431 · Received May 2, 2011

    Report

    Report Number
    3004209178-2011-03187
    Event Type
    Malfunction
    Date Received
    May 2, 2011
    Date of Event
    April 1, 2011
    Report Date
    April 12, 2011
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO., JUNCOS
    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 THE PATIENT HAD AN IMPEDANCE MEASUREMENT OF <50 OHMS ON ELECTRODE #1. IT WAS NOTED THAT IMPEDANCES WERE NORMAL AT IMPLANTATION. THE PATIENT DID NOT REPORT ANY FALLS OR OTHER TRAUMA RELATED TO THIS EVENT. THE COMPANY REPRESENTATIVE REPROGRAMMED THE PATIENT WITHOUT USING ELECTRODE #1 AND APPROPRIATE STIMULATION RESPONSE WAS OBTAINED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 RESTORE PRIME ADVANCED LGW MEDTRONIC PUERTO RICO OPERATIONS CO., JUNCOS 37702 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 85 YR IMPLANTED:| PROGRAMMER: MODEL 37743, LOT# NKE165449N| LEAD: MODEL 3778, LOT# V660349010| EXPLANTED:| STIM ACCESSORY: MODEL 3550-29, LOT# N280025| IMPLANTED:| EXPLANTED: