BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PRIMEADVANCED

    MDR report key: 4102117 · Received September 19, 2014

    Report

    Report Number
    3004209178-2014-17378
    Event Type
    Malfunction
    Date Received
    September 19, 2014
    Date of Event
    June 4, 2014
    Report Date
    August 28, 2014
    Manufacturer
    MEDTRONIC MED REL MEDTRONIC PUERTO RICO
    Product Code
    LGW
    PMA / PMN Number
    P840001
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AZ, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    CONCOMITANT MEDICAL PRODUCTS: PRODUCT ID: 3777Q60, SERIAL# (B)(4), IMPLANTED: (B)(6) 2013, PRODUCT TYPE: LEAD. PRODUCT ID: 3777Q60, SERIAL# (B)(4), IMPLANTED: (B)(6) 2013, PRODUCT TYPE: LEAD. PRODUCT ID: 37744Q, SERIAL# (B)(4), PRODUCT TYPE: PROGRAMMER, PATIENT. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED ELECTRODE THREE SHOWED IMPEDANCE GREATER THAN 10,000 OHMS WHEN TESTING AT 0.7 VOLTS. THE PATIENT DID NOT HAVE ANY SIGNS OR SYMPTOMS. THE INTERVENTION INCLUDED REPROGRAMMING AND THE EVENT WAS ONGOING AT THE TIME OF REPORT. THE EVENT WAS NOT RELATED TO THE IMPLANT PROCEDURE AND NOT APPLICABLE TO THE DEVICE OR THERAPY. IF ADDITIONAL INFORMATION ABOUT OUTCOME IS RECEIVED, A FOLLOW-UP REPORT WILL BE SENT.

    Description of Event or Problem · 1

    IT WAS LATER REPORTED THAT THE OUTCOME WAS UPDATED TO ONGOING WITH NO FURTHER ACTION NEEDED. REPROGRAMMING WAS DONE AGAIN. IMPEDANCE MEASUREMENTS WERE TAKEN AND ELECTRODE IMPEDANCE RESULTS INCLUDED MANY PAIRS THAT WERE GREATER THAN 10,000. PRINT OUT SHOWED ELECTRODE IMPEDANCE AT 0.70 AMPLITUDE HAVING SOME ELECTRODES OUT OF RANGE; ALL COMBINATIONS WITH 3 WERE >10,000. OTHER IMPEDANCE VALUES WERE 1-1787, 2-2239, 3- >10,000, 4-1973, 5-1777, 6-4887, 7-8145, 8-1973, 9-2269, 10-2051, 11-2276, 12-2307, 13-2225, 14-2254, 15-2051. NEUROSTIMULATOR STATUS WAS OK. THE INS CLOCK HAD CHANGED. THERE WERE NO PATIENT SYMPTOMS. BATTERY LONGEVITY ESTIMATION WAS DONE; ESTIMATED BATTERY LIFE FROM DATE OF IMPLANT WHICH WAS (B)(6) 2013 WAS 13 MONTHS AND ESTIMATED BATTERY LIFE CURRENTLY REMAINING WAS 0 MONTHS.

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION RECEIVED FROM A MANUFACTURER REPRESENTATIVE REPORTED THE EVENT REPORTED IN MFR REPORT # 3007566237-2015-02145, PERTAINS TO THIS EVENT AND ALL ADDITIONAL INFORMATION RECEIVED WILL BE REPORTED IN MFR REPORT # 3004209178-2014-17378. MFR REPORT # 3007566237-2015-02145 INDICATED THERE WERE NO HIGH IMPEDANCES AND THE PATIENT WAS EXPLANTED AND DISCONTINUED FROM THE STUDY, BUT IT WAS LATER DETERMINED THIS INFORMATION DID NOT PERTAIN TO THE PATIENT INVOLVED IN THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    584133 PRIMEADVANCED STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF LGW MEDTRONIC MED REL MEDTRONIC PUERTO RICO 37702

    Patients

    Seq Age Sex Outcome Treatment
    1 00042 YR