BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RESTORE RECHARGEABLE NEUROSTIMULATOR

    MDR report key: 2244017 · Received August 24, 2011

    Report

    Report Number
    3004209178-2011-06767
    Event Type
    Malfunction
    Date Received
    August 24, 2011
    Date of Event
    August 2, 2011
    Report Date
    August 2, 2011
    Manufacturer
    MDT 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

    SEE MANUFACTURER'S REPORT # 3004209178-2011-06075 FOR ISSUE LEADING TO THIS EVENT. ON (B)(6) 2011 THE IPG WAS REPLACED FROM A PRIME ADVANCE MODEL TO A RESTORE DEVICE. THE PATIENT HAD STIM PRIOR TO THE END OF SERVICE OF THE PRIME ADVANCE MODEL. WITH DIRECT CONNECT IT APPEARED TWO OF THE WIRES WERE WRAPPED AROUND EACH OTHER. INSULATION APPEARED IT MAY HAVE BEEN COMPROMISED. THERE WAS AN IMPEDANCE ISSUE 11 GREATER THAN 3600. ALL BIPOLES WITH CHANGING REFERENCES 0-7 WERE LESS THAN 70. THERE WAS A LOW OUT OF RANGE IMPEDANCE VALUE. IT WAS ALSO NOTED THAT THERE WERE ELECTRODE IMPEDANCES THAT WERE GREATER THAN 70. PROGRAMMING WAS PERFORMED TO FIND COMBINATIONS SO THAT THE IMPEDANCES WERE IN NORMAL RANGE AND THEY WERE ABLE TO GET GOOD COVERAGE. THE PATIENT WAS INFORMED TO MONITOR HOW OFTEN THEY WERE HAVING TO RECHARGE. IN A FOLLOW UP WITH THE PATIENT ON (B)(6) 2011, IT WAS NOTED THAT THE PATIENT WAS DOING WELL WITH GOOD COVERAGE. ALL IMPEDANCES WERE WITHIN NORMAL LIMITS EXCEPT FOR ELECTRODE 3 WAS GREATER THAN 3600. EACH ELECTRODE WAS CHECKED AS A REFERENCE. THE PATIENT WAS NOT HAVING ANY PROBLEMS WITH THEIR SYSTEM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 RESTORE RECHARGEABLE NEUROSTIMULATOR LGW MDT PUERTO RICO OPERATIONS CO., JUNCOS 37711 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 IMPLANTED:| IMPLANTABLE NERUO STIMULATOR: MODEL 37702| LEAD: MODEL 3778, LOT# V4749520202| LOT# NKL715993H| IMPLANTED:| EXPLANTED:| IMPLANTED:| PROGRAMMER: MODEL 37743, LOT# NKE149522N| EXPLANTED:| IMPLANTED:| LEAD: MODEL 3778, LOT# V474952021| EXPLANTED:| EXPLANTED: