BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RESTORE ADVANCED

    MDR report key: 2446572 · Received February 10, 2012

    Report

    Report Number
    3004209178-2012-00924
    Event Type
    Malfunction
    Date Received
    February 10, 2012
    Report Date
    January 16, 2012
    Manufacturer
    MDT PUERTO RICO OPERATIONS CO
    Product Code
    LGW
    PMA / PMN Number
    P840001
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    CONCOMITANT MEDICAL PRODUCTS: LEAD MODEL 3887-45 LOT# V022293 IMPLANTED: (B)(6) 2007 EXPLANTED: NA. LEAD MODEL 3887-45 LOT# V022293 IMPLANTED: (B)(6) 2007 EXPLANTED: NA. LEAD MODEL 377860 LOT# V020880 IMPLANTED: (B)(6) 2007 EXPLANTED: NA. EXTENSION MODEL 3708220 SERIAL# (B)(4) IMPLANTED: (B)(6) 2007 EXPLANTED: NA. PROGRAMMER MODEL 37742 SERIAL# (B)(4). RECHARGER 37752 SERIAL# (B)(4).

    Additional Manufacturer Narrative · 1

    CONCOMITANT MEDICAL PRODUCTS: PRODUCT ID: 37754, SERIAL# (B)(4), PRODUCT TYPE: RECHARGER. PRODUCT ID: 37744, LOT# SERIAL# (B)(4), PRODUCT TYPE: PROGRAMMER, PATIENT. PRODUCT ID: 37714, SERIAL# (B)(4), IMPLANTED: 2012-(B)(6), PRODUCT TYPE: IMPLANTABLE NEUROSTIMULATOR. PRODUCT ID: 3887-45, LOT# V022293, IMPLANTED: 2007-(B)(6), PRODUCT TYPE: LEAD. PRODUCT ID: 377860, LOT# V020880, IMPLANTED: 2007-(B)(6), PRODUCT TYPE; LEAD. PRODUCT ID: 37742, SERIAL# (B)(4), PRODUCT TYPE: PROGRAMMER, PATIENT. PRODUCT ID: 3708220, SERIAL# (B)(4), PRODUCT TYPE: EXTENSION. PRODUCT ID: 37752, SERIAL# (B)(4), PRODUCT TYPE: RECHARGER. (B)(4).

    Description of Event or Problem · 1

    DURING A REVISION OF THE INS, IT WAS DISCOVERED 0-7 WAS OUT OF RANGE. THE IMPEDANCE MEASUREMENTS WERE GREATER THAN 10,000 AND 20,000 OHMS. THERE WAS NO PRIOR HISTORY ON IMPEDANCES AVAILABLE AND IT WAS UNCLEAR IF THE PATIENT WAS HAVING ANY PROBLEMS GOING INTO THE PROCEDURE. THE EXTENSIONS WERE SWITCHED AND THEN 8-15 WERE HIGH. TESTING AT 3V YIELDED GREATER THAN 40,000 OHMS ON 0-7. WHEN THE EXTENSIONS WERE SWITCHED BACK SOME WERE AT 35,000 TO 36,000 OHMS. IT WAS CONFIRMED THAT THE ONLY DIAGNOSTICS PERFORMED WERE INTRAOPERATIVE IMPEDANCES. IT WAS DETERMINED THAT THE IMPEDANCES WERE ONLY TEMPORARILY OUT OF RANGE. THEY WERE ABLE TO PROGRAM THE PATIENT'S LEAD AND PROVIDE EFFECTIVE COVERAGE OF HIS PAINFUL AREAS. THE PATIENT WAS DOING WELL AND WAS WITHOUT COMPLAINT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 RESTORE ADVANCED STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF LGW MDT PUERTO RICO OPERATIONS CO 37713

    Patients

    Seq Age Sex Outcome Treatment
    1