BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SYNERGY

    MDR report key: 1220441 · Received October 31, 2008

    Report

    Report Number
    3004209178-2008-07089
    Event Type
    Injury
    Date Received
    October 31, 2008
    Date of Event
    October 1, 2007
    Report Date
    October 6, 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
    MN, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE WAS RETURNED TO THE MANUFACTURER FOR ANALYSIS. ANALYSIS HAS NOT BEEN COMPLETED, SECONDARY TO LACK OF LEGAL PERMISSION TO DISCONNECT THE CUT-THRU EXTENSIONS FROM THE DEVICE, SO IT CAN BE HOOKED UP TO THE AUTOMATIC TESTING CONSOLE. PERMISSION HAS BEEN REQUESTED.

    Additional Manufacturer Narrative · 1

    (B)(4).

    Additional Manufacturer Narrative · 1

    CONCOMITANT MEDICAL PRODUCTS: PRODUCT ID: 389133, LOT# J0511641V, IMPLANTED: (B)(6) 2005, EXPLANTED: (B)(6) 2007, PRODUCT TYPE: LEAD. PRODUCT ID: 389133, LOT# J0511641V, IMPLANTED:(B)(6) 2005, EXPLANTED: (B)(6) 2007, PRODUCT TYPE: LEAD. PRODUCT ID: 3550-39, EXPLANTED: (B)(6) 2007, PRODUCT TYPE: ACCESSORY. PRODUCT ID: 3550-39, EXPLANTED: (B)(6) 2007, PRODUCT TYPE: ACCESSORY. PRODUCT ID: 748925, SERIAL# (B)(4), IMPLANTED: (B)(6) 2005, EXPLANTED: (B)(6) 2007, PRODUCT TYPE: EXTENSION. PRODUCT ID: 748925, SERIAL# (B)(4), IMPLANTED: (B)(6) 2005, EXPLANTED: (B)(6) 2007, PRODUCT TYPE: EXTENSION. PRODUCT ID: 7435, SERIAL# (B)(4), IMPLANTED: (B)(6) 2005, EXPLANTED: (B)(6) 2007, PRODUCT TYPE: PROGRAMMER, PATIENT. (B)(4)

    Description of Event or Problem · 1

    IT WAS REPORTED THAT SOMETHING WAS WITH THE NEUROSTIMULATOR CAUSING PREMATURE BATTERY DEPLETION. THE NEUROSTIMULATOR WAS EXPLANTED AFTER 8 MONTHS OF USE. THE BATTERY VOLTAGE WAS 2.05 VOLTS AT EXPLANT. THE PATIENT EXPERIENCED CESSATION OF STIMULATION.

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION REPORTED THAT THERE WAS NO PATIENT INJURY AND THE PATIENT RECOVERED WITHOUT SEQUELAE. ADDITIONAL INFORMATION RECEIVED REPORTED THAT THE PATIENT'S DEVICE WAS REPLACED.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 56 YR Required Intervention EXTENSION: MODEL 7489| IMPLANTED:| EXTENSION: MODEL 7489| EXPLANTED:| IMPLANTED:| STIM ACCESSORY: MODEL TITAN ANCHR LOT # UNK| EXPLANTED:| PROGRAMMER: MODEL 7435| IMPLANTED:| IMPLANTED:| EXPLANTED:| EXPLANTED:| STIM ACCESSORY: MODEL TITAN ANCHR| EXPLANTED:| LEAD: MODEL 3891| IMPLANTED:| EXPLANTED:| LEAD:MODEL 3891 LOT # J0511641V