BEUDAMED
    FDA Adverse Event Injury Summary report: N

    RESTORE ADVANCED RECHARGEABLE

    MDR report key: 1002340 · Received February 22, 2008

    Report

    Report Number
    3004209178-2008-00892
    Event Type
    Injury
    Date Received
    February 22, 2008
    Date of Event
    January 20, 2008
    Report Date
    January 23, 2008
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO
    Product Code
    LGW
    PMA / PMN Number
    P840001
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MO, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE HAS BEEN RETURNED TO THE MFR FOR ANALYSIS WHICH IS NOT COMPLETE AS OF THE DATE OF THIS REPORT. A FOLLOW-UP REPORT WILL BE SENT WHEN THE ANALYSIS IS COMPLETED.

    Description of Event or Problem · 1

    IT WAS REPORTED BY THE PT THAT HE WAS NOT ABLE TO ADJUST STIMULATION. PARTICULARLY UNABLE TO DECREASE STIMULATION. IT WAS FURTHER REPORTED THE PT EXPERIENCED SHOCKING AND JOLTING SENSATIONS AND WAS ADMITTED TO THE ER. THE MFR'S REP NOTED THE PT WAS IN SIGNIFICANT DISTRESS WITH PERIODIC GROANING, GRITTING OF TEETH, TOTAL BODY SHAKES AND SPASMS. THE DEVICE WAS INTERROGATED IN THE ER AND FOUND TO BE OFF AND AT ZERO VOLTS. ADDITIONALLY, ALL OF THE IMPEDANCES WERE CHECKED AND WERE WITHIN NORMAL LIMITS. RADIOGRAPHS WERE TAKEN AS PT'S SYMPTOMS INCREASED IN SUPINE POSITION REQUIRED FOR CT SCAN. UPON VISUALIZATION OF RADIOGRAPHS THE GENERATOR, LEADS, AND EXTENSION WIRES ALL APPEARED INTACT. THE HCP ADMITTED THE PT FOR EXPLORATORY SURGERY, ALTHOUGH THE PT REQUESTED DEVICE BE EXPLANTED. THE DEVICE SYSTEM WAS EXPLANTED THE NEXT DAY AT THE PT'S REQUEST. THE EXPLANTED SYSTEM APPEARED INTACT. THE SHOCKING SYMPTOMS DISSIPATED POST EXPLANTATION, ALTHOUGH THE PT CONTINUES TO REQUIRE HIGH DOSES OF PAIN MEDICATION.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 YR Hospitalization| R LEAD MODEL 3778 LOT# V040681027| IMPLANTED| IMPLANTED| IMPLANTED| IMPLANTED| EXPLANTED| EXPLANTED| IMPLANTED| EXPLANTED| LEAD MODEL 3487A LOT# J0537489V| IMPLANTED| LEAD MODEL 3487A LOT# V038162| EXTENSION MODEL 37082 LOT# NKB008806N| EXPLANTED| ACCESSORY MODEL 37752 LOT# NKA031825N| EXPLANTED| EXPLANTED| PROGRAMMER MODEL 37742 LOT# NJD048623N