BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SYNERGY

    MDR report key: 4093052 · Received September 16, 2014

    Report

    Report Number
    3004209178-2014-17094
    Event Type
    Injury
    Date Received
    September 16, 2014
    Report Date
    August 20, 2014
    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

    CONCOMITANT MEDICAL PRODUCTS: PRODUCT ID 748951, SERIAL# (B)(4), IMPLANTED: (B)(6) 2006, PRODUCT TYPE: EXTENSION; PRODUCT ID 3487A-33, LOT# V009141, IMPLANTED: (B)(6) 2006, PRODUCT TYPE: LEAD; PRODUCT ID 7496-51, SERIAL# (B)(4), IMPLANTED: (B)(6) 1994, PRODUCT TYPE: EXTENSION; PRODUCT ID 7434-E, SERIAL# (B)(4), IMPLANTED: (B)(6) 1998, PRODUCT TYPE: PROGRAMMER, PATIENT; PRODUCT ID 3982, SERIAL# (B)(4), IMPLANTED: (B)(6) 1994, PRODUCT TYPE: LEAD; PRODUCT ID 8840, PRODUCT TYPE: PROGRAMMER, PHYSICIAN. (B)(4). ANALYSIS RESULTS WERE NOT AVAILABLE AS OF THE DATE OF THIS REPORT. A FOLLOW-UP REPORT WILL BE SUBMITTED WHEN ANALYSIS IS COMPLETE.

    Additional Manufacturer Narrative · 1

    ANALYSIS OF THE IMPLANTABLE NEUROSTIMULATOR (INS) FOUND THAT THERE WAS NO SIGNIFICANT ANOMALY. THE BATTERY WAS NOT IN NEW CONDITION.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE CALLER WAS UNABLE TO INCREASE STIMULATION WITH THE PATIENT PROGRAMMER. THE CALLER WAS GETTING A ¿TRIPLE BEEP MESSAGE¿ BUT COULD TURN THE IMPLANTABLE NEUROSTIMULATOR (INS) ON AND OFF AND DECREASE VOLTAGE. THE PATIENT ALSO HAD THIS ISSUE AT HOME WITH THE PATIENT PROGRAMMER. THE PATIENT INDICATED SHE HAD BEEN GETTING A TRIPLE BEEP FROM THE PATIENT PROGRAMMER FOR OVER A YEAR. STIMULATION COULD BE TURNED UP USING THE CLINICIAN PROGRAMMER. PROGRAM ONE WAS 0.7V AND PROGRAM TWO WAS 3V AND SO THE PATIENT SHOULD NOT BE HITTING THE UPPER LIMIT. IT WAS CONFIRMED WITH THE CALLER THAT THE UPPER LIMIT WAS PROGRAMMED CORRECTLY. THE CLINICIAN PROGRAMMER WOULD NOT LET THE CALLER DO A CHECK OF THE IMPLANTABLE NEUROSTIMULATOR (INS) BATTERY. THERE WAS NOT ANY POWER ON RESETS (POR) EVIDENT. IMPEDANCES WERE ALL IN A NORMAL RANGE IN 690S FOR MOST PAIRS WITH A COUPLE OF 452 VALUES. THE 0-2 PAIR WAS ¿???¿ BUT ALL OTHER PAIRS WITH 2 WERE 690. THE INS WAS AT 80-90% USED AT 2.4V. REPROGRAMMING WAS SUCCESSFULLY DONE ON THE DATE OF REPORT TO GET MORE STIMULATION IN THE BACK. LATER, IT WAS REPORTED THAT THE PATIENT HAD THE INS REPLACED (B)(6) 2014. ALL IMPEDANCES ON THE NEW DEVICE WERE WITHIN NORMAL LIMITS. THE INS WAS RETURNED. THE PATIENT WAS RECEIVING EFFECTIVE THERAPY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    573344 SYNERGY STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF LGW MEDTRONIC MED REL MEDTRONIC PUERTO RICO 7427

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention