BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SOLETRA

    MDR report key: 2211905 · Received August 10, 2011

    Report

    Report Number
    3004209178-2011-06214
    Event Type
    Malfunction
    Date Received
    August 10, 2011
    Date of Event
    February 1, 2011
    Report Date
    July 18, 2011
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO., JUNCOS
    Product Code
    MHY
    PMA / PMN Number
    P960009/S7
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    UNKNOWN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT LOWER IMPEDANCE READINGS WERE ENCOUNTERED ON CASE COMBOS. ALSO, IMPEDANCE READINGS WERE GREATER THEN 4,000 OHMS. ALL COMBOS WITH 0 WERE GREATER THAN 4,000 OHMS WITH 8 OR 9 UA. ELECTRODES 1 - 2 WERE LESS THAN 50 OHMS. THE THERAPY IMPEDANCE WAS 427 OHMS. THERE WAS LOW, OUT OF RANGE, IMPEDANCE VALUE READ. THE IMPEDANCE READINGS WERE NOTED TO BE "VERY SIMILAR" TO THOSE READINGS SEEN PRIOR TO THE EXPLANT OF THE PT'S PREVIOUS IMPLANTABLE NEUROSTIMULATOR. THE PT EXPERIENCED A LOSS OF THERAPEUTIC EFFECT AND HAS HAD ONLY PARTIAL BENEFIT SINCE THE NEUROSTIMULATOR WAS IMPLANTED. THE PT WAS "DOING EVEN WORSE NOW." THE PT'S DEVICE WAS PROGRAMMING TO C 23 AND 13, BUT ONLY PARTIAL BENEFIT WAS ACHIEVED WITH THESE COMBINATIONS. NO INFO WAS PROVIDED RELATED TO THE PT'S OUTCOME. ADD'L INFO WAS REQUESTED, BUT NOT AVAILABLE AS OF THE DATE OF THIS REPORT. A F/U REPORT WILL BE FILED IF ADD'L INFO BECOMES AVAILABLE. SEE ALSO MFR REPORT# 3004209178-2011-06213. ALSO SEE MFR REPORT#S 3004209178-2011-00474 AND 00475 FOR INFO RELATED TO THE PT'S PREVIOUSLY IMPLANTED NEUROSTIMULATOR.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SOLETRA MHY MEDTRONIC PUERTO RICO OPERATIONS CO., JUNCOS 7426 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 58 YR EXPLANTED:| IMPLANTED:| IMPLANTED:| EXPLANTED:| IMPLANTED:| EXPLANTED:| EXTENSION: MODEL 7482, LOT# NHU178321V| IMPLANTED:| EXTENSION: MODEL 7482, LOT# NHU178421V| IMPLANTABLE NEURO STIMULATOR: MODEL 7426| LOT# NFW169437H| EXPLANTED:| LEAD: MODEL 3387, LOT# V039858| IMPLANTED:| EXPLANTED:| LEAD: MODEL 3387, LOT# V113842