BEUDAMED
    FDA Adverse Event Injury Summary report: N

    RESTORE

    MDR report key: 3080004 · Received April 26, 2013

    Report

    Report Number
    3004209178-2013-06950
    Event Type
    Injury
    Date Received
    April 26, 2013
    Report Date
    April 10, 2013
    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
    MN, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Additional Manufacturer Narrative · 1

    PRODUCT ID: 37742 LOT# SERIAL# (B)(4), IMPLANTED: 2005 (B)(6), PRODUCT TYPE PROGRAMMER, PATIENT PRODUCT ID: 377760 LOT# V000468, IMPLANTED: 2005 (B)(6), PRODUCT TYPE LEAD PRODUCT ID: 377760 LOT# V000468, IMPLANTED: 2005 (B)(6), PRODUCT TYPE LEAD. (B)(4).

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT WAS FREE OF THE PAIN. IT WAS NOTED THAT THE PATIENT HAD NOT WORN THE STIMULATOR FOR "AT LEAST TWO YEARS" BUT HAD KEPT IT CHARGED. IT WAS NOTED THAT THE PATIENT HAD NOT TURNED HIS SYSTEM ON IN AT LEAST ONE MONTH PRIOR TO THE REPORT. IT WAS NOTED THAT THERE WERE HIGH IMPEDANCES AND CONTACTS 0-7 HAD MEASUREMENTS OF OVER 3600 OHMS. IT WAS NOTED THAT THE PATIENT WANTED HIS STIMULATOR EXPLANTED SINCE HE WAS "PAIN FREE." THERE WERE NO PATIENT SYMPTOMS OR INJURIES RELATED TO THIS EVENT. ADDITIONAL INFORMATION WAS REQUESTED, BUT WAS NOT AVAILABLE AS OF THE DATE OF THIS REPORT.

    Description of Event or Problem · 1

    FOLLOW UP INFORMATION REPORTED NO DIAGNOSTICS WERE PERFORMED AND THE PATIENT¿S IMPLANTABLE NEUROSTIMULATOR (INS) COULD NOT BE INTERROGATED BECAUSE THE PATIENT HAD QUIT CHARGING THE BATTERY. FURTHER FOLLOW UP INFORMATION RECEIVED REPORTED THAT THE PATIENT¿S INS DEVICE WAS EXPLANTED. IT WAS NOTED THAT THE PATIENT HAD A WORKERS COMPENSATION INJURY AND USED THE DEVICE THROUGHOUT THEIR REHABILITATION. ONCE THEIR REHABILITATION WAS COMPLETED THE PATIENT¿S PAIN WAS GONE. THE PATIENT MAINTAINED A CHARGE ON THE INS FOR THE LAST YEAR BUT WAS NOT USING IT FOR PAIN RELIEF BECAUSE THEY WERE WELL. IT WAS REPORTED THAT THE REASON FOR THE EXPLANT WAS THAT THE PATIENT NEEDED AN MRI. IT WAS NOTED THAT THE IMPEDANCE ISSUES WERE LIKELY DUE TO A FALL AT THE PATIENT¿S WORKPLACE BUT WERE NOT THE CAUSE FOR THE EXPLANTATION. IF ADDITIONAL INFORMATION IS RECEIVED, A FOLLOW UP REPORT WILL BE SENT.

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION INDICATED THAT THE PATIENT AND THE SURGEON WERE IN THE PROCESS OF SCHEDULING HIS SURGERY LATER IN THE SUMMER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    182302 RESTORE STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF LGW MEDTRONIC MED REL MEDTRONIC PUERTO RICO 37711

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention