BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RESTORE

    MDR report key: 1080253 · Received July 22, 2008

    Report

    Report Number
    3004209178-2008-04229
    Event Type
    Malfunction
    Date Received
    July 22, 2008
    Date of Event
    June 1, 2008
    Report Date
    June 27, 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
    GA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    PRODUCT ID: 377760, LOT# J0555232V, IMPLANTED: (B)(6) 2005, EXPLANTED: (B)(6) 2008, PRODUCT TYPE: LEAD; PRODUCT ID: 377760, LOT# J0555232V, IMPLANTED: (B)(6) 2005, EXPLANTED: (B)(6) 2008, PRODUCT TYPE: LEAD; PRODUCT ID: 37742, SERIAL# (B)(4), PRODUCT TYPE: PROGRAMMER, PATIENT; PRODUCT ID: 37752, SERIAL# (B)(4), PRODUCT TYPE: RECHARGER.

    Description of Event or Problem · 1

    THE PATIENT EXPERIENCED STIMULATION IN THE WRONG LOCATION AFTER ARCHING HER BACK OVER AN EXERCISE BALL. THE PATIENT WAS ENCOURAGED TO CONTACT HER HCP. ADDITIONAL INFORMATION HAS BEEN REQUESTED FROM THE HCP, A FOLLOW-UP REPORT WILL BE SENT IF ADDITIONAL INFORMATION BECOMES AVAILABLE.

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION REPORTED THAT THE PERCUTANEOUS LEADS SLIPPED. THEY WERE REPLACED WITH SURGICAL LEADS. IT WAS STATED THAT THE SURGERY TO IMPLANT THE SURGICAL LEADS "SUCKED" AND WAS 7 HOURS LONG. HER SURGICAL LEADS WERE PLACED PERFECTLY AND WERE AT T8.

    Description of Event or Problem · 1

    THE PATIENT EXPERIENCED PREEXISTING PAIN. THERE WAS A LACK OF APPROPRIATE STIMULATION COVERAGE, REFRACTORY TO REPROGRAMMING OF THE IMPLANTABLE NEUROSTIMULATOR. X-RAYS REVEALED ALTERED LEAD POSITION. THE LEAD WAS REVISED. THE HCP REPORTED THE PATIENT OUTCOME AS 'NO INJURY'.

    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 00038 YR Required Intervention LEAD MODEL 377760 IMPLANTED| PROGRAMMER MODEL 37742 LOT# NJD010224N| LEAD MODEL 377760 IMPLANTED| EXPLANTED| ACCESSORY MODEL 37752 LOT# NKA012538N| EXPLANTED