BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RESTORE ADVANCED RECHARGEABLE

    MDR report key: 2182178 · Received July 7, 2011

    Report

    Report Number
    3004209178-2011-05162
    Event Type
    Malfunction
    Date Received
    July 7, 2011
    Date of Event
    January 1, 2011
    Report Date
    June 13, 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
    OH, US
    Reporter Occupation
    UNKNOWN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    THE PT EXPERIENCED A SHOCKING OR JOLTING SENSATION IN HER FEET AND A LOSS OF STIMULATION SENSATION. THE SHOCKING BEGAN A FEW MONTHS BEFORE THE LOSS OF STIMULATION. SHE INCREASED HER STIMULATION TO THE MAXIMUM LEVEL OF 10.5V, BUT COULD NOT FEEL ANYTHING. HER IMPLANTABLE NEUROSTIMULATOR (INS) WAS ABLE TO COMMUNICATE WITH HER PT PROGRAMMER AND RECHARGER. THE PT DESCRIBED HER CONDITION AS FAIR. IT WAS NOTED THAT THE PT FELL LAST WINTER. A MFR'S REP MET WITH THE PT AND MEASURED IMPEDANCES >40,000 OHMS. AT 3.0V IMPEDANCE READINGS WERE AS FOLLOWS: 1-2=39300, 1-3=29400, 1-5, 1-6, AND 1-7 WERE BETWEEN 700-800, 1-8=700, 1-12=767, 1-15=734 (ALL OTHER PAIRS >40000); 2-1=39300, 2-5=39804, 2-8=39996, 2-12=39489, 2-15=39996 (ALL OTHER PAIRS >40000); 5-2=39804, 5-3=28878, 5-6=583, 5-7=669, 5-8=704, 5-12=704, 5-15=638 (ALL OTHER PAIRS >40000); 6-1=700, 6-2=>40000, 6-3=34493, 6-4=>40000, 6-5=583, 6-7=519, 6-8=578, 6-9=>40000, 6-10=>40000, 6-11=>40000, 6-12=607, 6-13=>40000, 6-14=>40000, 6-15=470; 7-1=742, 7-3=34113, 7-5=669, 7-6=519, 7-8=629, 6-12=653, 6-15=371 (ALL OTHER PAIRS >40000); 15-1=734, 15-2=23996, 15-3=29423, 15-5=638, 15-6=470, 15-7=371, 15-8=607, 15-12=633 (ALL OTHER PAIRS >40000); 8-1=708, 8-2=3996, 8-3=28878, 8-5=704, 8-6=578, 8-7=629, 8-12=666, 8-15=607 (ALL OTHER PAIRS > 40000). ADD'L INFO HAS BEEN REQUESTED, A FOLLOW UP REPORT WILL BE SENT IF ADD'L INFO BECOMES AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 RESTORE ADVANCED RECHARGEABLE LGW MEDTRONIC PUERTO RICO OPERATIONS CO., JUNCOS 37713 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 42 YR LEAD: MODEL 3777, LOT# V361217036| EXPLANTED:| IMPLANTED:| EXPLANTED:| LEAD: MODEL 3777, LOT# V357770004| IMPLANTED:| PROGRAMMER: MODEL 37743, LOT# NKE141382N