BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RESTORE PRIME ADVANCED

    MDR report key: 2030441 · Received March 9, 2011

    Report

    Report Number
    3004209178-2011-01771
    Event Type
    Malfunction
    Date Received
    March 9, 2011
    Date of Event
    February 23, 2011
    Report Date
    February 23, 2011
    Manufacturer
    MDT PUERTO RICO OPERATIONS CO., JUNCOS
    Product Code
    LGW
    PMA / PMN Number
    P840001
    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

    HIGH OUT-OF-RANGE IMPEDANCE INDICATIVE OF OPEN CIRCUITS WERE NOTED ON SOME OF THE BIPOLAR ELECTRODE PAIRS. THE IMPLANTABLE NEUROSTIMULATOR BATTERY WAS AT OR NEAR END OF SERVICE. IT WAS REPLACED (REFERENCE 6000032201009856). AFTER REPLACEMENT, POST OPERATIVE IMPEDANCES REMAINED OUT OF RANGE. THE CONTINUED PATTERN HIGH IMPEDANCES SUGGESTS THE CAUSE OF THE PROBLEM LAY WITH A LEAD OR EXTENSION. ADD'L INFO HAS BEEN REQUESTED. A F/U REPORT WILL BE SUBMITTED IF ADD'L INFO BECOMES AVAILABLE.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 40 YR LOT# NFE114665H| LEAD: MODEL 3487A, LOT# J0120768V| EXPLANTED:| IMPLANTED:| IMPLANTED:| EXPLANTED:| EXPLANTED:| LEAD: MODEL 3487A, LOT# J0118495V| IMPLANTED:| EXPLANTED:| IMPLANTABLE NEURO STIMULATOR: MODEL 7427| PROGRAMMER: MODEL 37743, LOT# NKE160032N| IMPLANTED:| ADAPTER: MODEL 74002, LOT# N251312| EXPLANTED:| PROGRAMMER: MODEL 7435, LOT# NFT012374P| EXPLANTED:| IMPLANTED:| EXTENSION: MODEL 7489, LOT# NHU008138V| EXTENSION: MODEL 7489, LOT# NHU008135V| EXPLANTED:| IMPLANTED:| IMPLANTED: