BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SYNERGY

    MDR report key: 3112414 · Received May 14, 2013

    Report

    Report Number
    3004209178-2013-07657
    Event Type
    Malfunction
    Date Received
    May 14, 2013
    Report Date
    May 14, 2013
    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
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Additional Manufacturer Narrative · 1

    (B)(4).

    Additional Manufacturer Narrative · 1

    (B)(4).

    Additional Manufacturer Narrative · 1

    CONCOMITANT MEDICAL PRODUCTS: PRODUCT ID 7435, SERIAL# (B)(4), IMPLANTED: (B)(6) 2005. PRODUCT TYPE: PROGRAMMER, PATIENT: PRODUCT ID 7495LZ25, SERIAL# (B)(4), IMPLANTED: (B)(6) 2002. PRODUCT TYPE: EXTENSION: PRODUCT ID 3888-28, LOT# L45885, IMPLANTED: (B)(6) 1997. PRODUCT TYPE: LEAD: PRODUCT ID 7495LZ25, SERIAL# (B)(4), IMPLANTED: (B)(6) 2002. PRODUCT TYPE: EXTENSION: PRODUCT ID 3888-28, LOT# L47256, IMPLANTED: (B)(6) 1997. PRODUCT TYPE: LEAD. (B)(4).

    Description of Event or Problem · 1

    IT WAS LATER REPORTED THAT AT THE PATIENT¿S DOCTOR VISIT ON (B)(6) 2013 WHEN THE DOCTOR WAS ¿REGULATING THE STIMULATOR, THERE WAS SOME COMPLICATIONS AND HE BELIEVED ONE OF THE LEADS KIND OF POPPED OUT".

    Description of Event or Problem · 1

    UPON FURTHER REVIEW, IT WAS REPORTED THAT MANUFACTURER¿S REPRESENTATIVE WAS GETTING QUESTION MARKS DURING IMPEDANCE TESTING.

    Description of Event or Problem · 1

    THE PATIENT HAS EXPERIENCED A SHOCKING/JOLTING SENSATION AND UNCOMFORTABLE STIMULATION AT LEAD LOCATION SINCE A CAR ACCIDENT IN (B)(6). WHEN PRESSING THE DEVICE SITE, THE SHOCKING/JOLTING SENSATION INCREASES. ONCE RELEASED THE STIMULATION CHANGES. PRIOR TO THE ACCIDENT HE RECEIVED GREAT COVERAGE. HIS NEUROSURGEON THOUGHT THE LEAD HAD MOVED. THE IMPEDANCE MEASUREMENTS WERE GREATER THAN 4,000 OHMS ON SOME OF THE BIPOLAR PAIRS AND WITH ALL CONTACTS PAIRED WITH ELECTRODE 6. BATTERY VOLTAGE WAS MEASURED AT 2.94V. IT WAS CLARIFIED THE PATIENT LOST STIMULATION IN HIS BACK AND THERAPEUTIC EFFECT ON THE RIGHT SIDE. ELECTRODE 6 WAS NO LONGER FUNCTIONING AND THE DEVICE WAS REPROGRAMMED AROUND IT. REPROGRAMMING THE DEVICE MADE IT BETTER BUT THE THERAPY WAS NOT AS GOOD AS IT WAS BEFORE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    212578 SYNERGY STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF LGW MEDTRONIC MED REL MEDTRONIC PUERTO RICO 7427

    Patients

    Seq Age Sex Outcome Treatment
    1