BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RESTORE ULTRA

    MDR report key: 2708397 · Received August 22, 2012

    Report

    Report Number
    3004209178-2012-07184
    Event Type
    Malfunction
    Date Received
    August 22, 2012
    Report Date
    July 26, 2012
    Manufacturer
    MEDTRONIC MED REL MEDTRONIC PUERTO RICO
    Product Code
    LGW
    PMA / PMN Number
    P840001
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    CONCOMITANT MEDICAL PRODUCTS: LEAD: MODEL 3888-56, LOT # V247274, IMPLANTED: (B)(6) 2009, EXPLANTED: NA. LEAD: MODEL 3888-33, LOT # V248575, IMPLANTED: (B)(6) 2009, EXPLANTED: NA. LEAD: MODEL 3487A-45, LOT # V241049, IMPLANTED: (B)(6) 2009, EXPLANTED: NA. LEAD: MODEL 3487A-45, LOT # V241049, IMPLANTED: (B)(6) 2009, EXPLANTED: NA. LEAD: MODEL 3888-56, LOT # V247274, IMPLANTED: (B)(6) 2009, EXPLANTED: NA. LEAD: MODEL 3888-56, LOT # V250969, IMPLANTED: (B)(6) 2009, EXPLANTED: NA. EXTENSION: MODEL 3708260, SERIAL # (B)(4), IMPLANTED: (B)(6) 2009, EXPLANTED: NA. EXTENSION: MODEL 3708260, SERIAL # (B)(4), IMPLANTED: (B)(6) 2009, EXPLANTED: NA. RECHARGER: MODEL 37752, SERIAL # (B)(4). PROGRAMMER: MODEL 37743, SERIAL # (B)(4). CONCOMITANT SYSTEM: NEUROSTIMULATOR: MODEL 37712, SERIAL # (B)(4), IMPLANTED: (B)(6) 2010, EXPLANTED: NA. LEAD: MODEL 3888-33, LOT #V327597, IMPLANTED: (B)(6) 2010, EXPLANTED: NA. LEAD: MODEL 3888-45, LOT #V372141, IMPLANTED: (B)(6) 2010, EXPLANTED: NA. LEAD: MODEL 3778-45, SERIAL # (B)(4), IMPLANTED: (B)(6) 2010, EXPLANTED: NA. EXTENSION: MODEL 3708160, SERIAL # (B)(4), IMPLANTED: (B)(6) 2010, EXPLANTED: NA. EXTENSION: MODEL 3708260, SERIAL # (B)(4), IMPLANTED: (B)(6) 2010, EXPLANTED: NA. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT COULD NOT ADJUST THEIR STIMULATION ON THEIR IMPLANTABLE NEUROSTIMULATOR (INS). IT WAS NOTED THAT THERE WAS A POWER-ON-RESET (POR) ON THE DEVICE. THE PATIENT WORKED WITH THE COMPANY REPRESENTATIVE TO CLEAR THE POR WHICH RESOLVED THE ISSUE. IF ADDITIONAL INFORMATION IS RECEIVED, A FOLLOW UP REPORT WILL BE SENT. SEE ALSO MANUFACTURERS REPORT # 3004209178-2012-07183.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 RESTORE ULTRA STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF LGW MEDTRONIC MED REL MEDTRONIC PUERTO RICO 37712

    Patients

    Seq Age Sex Outcome Treatment
    1