BEUDAMED
    FDA Adverse Event Injury Summary report: N

    RESTORE

    MDR report key: 1181386 · Received September 24, 2008

    Report

    Report Number
    3004209178-2008-06111
    Event Type
    Injury
    Date Received
    September 24, 2008
    Date of Event
    January 1, 2008
    Report Date
    August 29, 2008
    Manufacturer
    MEDTRONIC MED REL MEDTRONIC PUERTO RICO
    Product Code
    LGW
    PMA / PMN Number
    P840001
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Additional Manufacturer Narrative · 1

    PRODUCT ID: 3998, LOT# L95535, IMPLANTED: (B)(6) 2001, EXPLANTED: (B)(6) 2008, PRODUCT TYPE: LEAD; PRODUCT ID: 3708360, SERIAL# (B)(4), IMPLANTED: (B)(6) 2005, EXPLANTED: (B)(6) 2008, PRODUCT TYPE: EXTENSION; PRODUCT ID: 3708360, SERIAL# (B)(4), IMPLANTED: (B)(6) 2005, EXPLANTED: (B)(6) 2008, PRODUCT TYPE: EXTENSION; PRODUCT ID: 37742, SERIAL# (B)(4), IMPLANTED: (B)(6) 2005, PRODUCT TYPE: PROGRAMMER, PATIENT; PRODUCT ID: 37752, SERIAL# UNKNOWN, PRODUCT TYPE: RECHARGER. (B)(4).

    Description of Event or Problem · 1

    THE IMPLANTABLE NEUROSTIMULATOR TURNED OFF BY ITSELF ON TWO OCCASIONS DURING THE NIGHT. THERE WAS NO KNOWN INCIDENT OR ACCIDENT RELATED TO THE COMPLAINT. THE HCP HAD TAKEN AN X-RAY OF THE STIMULATOR AND EXTENSION AREA AND EVERYTHING APPEARED TO BE ALRIGHT. THE PT WAS AT HOME AT THE TIME OF THE REPORT; HIS STATUS WAS REPORTED TO BE 'GOOD'. ADDITIONAL INFORMATION HAS BEEN REQUESTED. A FOLLOW-UP REPORT WILL BE SUBMITTED IF ADDITIONAL INFORMATION BECOMES AVAILABLE.

    Description of Event or Problem · 1

    THE PATIENT EXPERIENCED A LOSS OF THERAPEUTIC EFFECT. HE FELT STIMULATION IN HIS LEGS, BUT NOT IN HIS BACK. THE IMPLANTABLE NEUROSTIMULATOR WOULD TURN OFF BY ITSELF AT NIGHT. THE HCP HAD DETERMINED THAT ELECTRODES 3 AND 8 WERE NOT WORKING (TYPE OF MALFUNCTION NOT SPECIFIED). THERE WAS NO KNOWN INCIDENT OR ACCIDENT RELATED TO THE COMPLAINT.

    Description of Event or Problem · 1

    THE PATIENT HAD THEIR NEUROSTIMULATOR AND LEADS REPLACED.

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION RECEIVED REPORTED THE ¿WIRES¿ WERE REPLACED BECAUSE THEY BROKE. IT WAS UNKNOWN WHAT CAUSED THE LEAD BREAK, BUT THE LEAD WAS FRACTURED ¿AT THE NEAR THE TERMINAL.¿ INTERVENTIONS INCLUDED A TOTAL REPLACEMENT OF THE LEAD, EXTENSION, AND OF THE IPG ON (B)(6) 2008. IT WAS NOTED ALL PARTS OF THE LEAD WERE EXPLANTED (LEAD AND EXTENSION). THE PATIENT RECOVERED WITHOUT PERMANENT IMPAIRMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 RESTORE STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF LGW MEDTRONIC MED REL MEDTRONIC PUERTO RICO 37711 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 67 YR Required Intervention EXTENSION: MODEL 37083| LEAD: MODEL 3998| IMPLANTED:| IMPLANTED:| RECHARGER: MODEL 37752| EXTENSION: MODEL 37083| PROGRAMMER: MODEL 37742| EXPLANTED:| IMPLANTED:| EXPLANTED:| EXPLANTED: