BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SYNERGY VERSITREL

    MDR report key: 4591531 · Received March 11, 2015

    Report

    Report Number
    3004209178-2015-04535
    Event Type
    Malfunction
    Date Received
    March 11, 2015
    Report Date
    February 16, 2015
    Manufacturer
    MEDTRONIC MED REL MEDTRONIC PUERTO RICO
    Product Code
    LGW
    PMA / PMN Number
    P840001
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    CONCOMITANT MEDICAL PRODUCTS: PRODUCT ID 748940, SERIAL# (B)(4), IMPLANTED: (B)(6) 2004, PRODUCT TYPE: EXTENSION; PRODUCT ID 7435, SERIAL# (B)(4), IMPLANTED: (B)(6) 2004, PRODUCT TYPE: PROGRAMMER, PATIENT; PRODUCT ID 3998, LOT# J0349162V, IMPLANTED: (B)(6) 2004, PRODUCT TYPE: LEAD; PRODUCT ID 748940, SERIAL# (B)(4), IMPLANTED: (B)(6) 2004, PRODUCT TYPE: EXTENSION. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THERE WERE IMPEDANCE READINGS GREATER THAN 4,000 OHMS IN SOME OF THE BIPOLAR PAIRS. THE PATIENT WAS HAVING IMPLANTABLE NEUROSTIMULATOR (INS) REPLACED DUE TO NORMAL BATTERY DEPLETION. THE THERAPY PRIOR TO REPLACEMENT WAS ADEQUATE. THEY WERE RUNNING IMPEDANCES ON THE INS AND NOTED CONCERNS REGARDING SOME OF THE CONTACTS. THERAPY IMPEDANCES WERE ALSO RAN AND THE VALUES FOR THE MOST PART SEEMED OKAY PARTICULARLY THERAPY IMPEDANCES. TEST AT 3V WERE: 01 ??? 02 3030 03 2983 04 ?? 05 ?? 06 ?? 07 >4K 12 1195 13 990 14 3030 15 843 16 990 17 3030 23 1195 24 3030 25 ?? 26 ?? 27 3030 34 3030 35 990 36 990 37 3030 45 2012 46. TEST AT 5V WERE: 01 754 02 1431 03 2017 04 3379 05 2017 06 2017 07 ??? 12 991 13 820 14 2528 15 754 16 820 17 2528 23 1105 24 ??? 25 1248 26 1248 27 3379 34 2528 35 991 36 991 37 ??? 45 1675 46 ?? 47 ?? 56 697 57 2528 67 2017. PROGRAM 1 (5+ 6- 7-) - 681OHMS AND PROGRAM 2 (2+ 3-) - 1195 OHMS. ON (B)(6) ADDITIONAL INFORMATION WAS RECEIVED INDICATING THAT THE PATIENT WAS DOING GREAT SINCE INS REPLACEMENT. THE COVERAGE WAS GREAT AND ALL IMPEDANCES WERE WITHIN NORMAL LIMIT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    168530 SYNERGY VERSITREL STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF LGW MEDTRONIC MED REL MEDTRONIC PUERTO RICO 7427V

    Patients

    Seq Age Sex Outcome Treatment
    1 00053 YR