BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RESTORE PRIME ADVANCED

    MDR report key: 2201335 · Received August 3, 2011

    Report

    Report Number
    3004209178-2011-06019
    Event Type
    Malfunction
    Date Received
    August 3, 2011
    Date of Event
    July 1, 2011
    Report Date
    July 8, 2011
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO., JUNCOS
    Product Code
    LGW
    PMA / PMN Number
    P840001
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MA, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT WHEN STIMULATION WAS TURNED ON, THERE WAS A LACK OF THERAPEUTIC EFFECT. THE PT CLAIMED WHEN HE LAID DOWN AT NIGHT, STIMULATION DID NOT TREAT HIS PAIN. PT STATED THAT WHEN HE TRIED TO INCREASE STIMULATION, THE STIMULATION FELT LIKE IT WAS ELECTROCUTING HIM.

    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 88 YR EXPLANTED:| IMPLANTED:| LEAD: MODEL 3778, LOT# V524624022| EXPLANTED:| IMPLANTED:| IMPLANTED:| LEAD: MODEL 3778, LOT# V312470009| PROGRAMMER: MODEL 37743, LOT# NKE161506N| EXPLANTED:| STIM ACCESSORY: MODEL 37092, LOT# 271470001| IMPLANTED:| EXPLANTED: