BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RESTORE SENSOR

    MDR report key: 2992414 · Received March 7, 2013

    Report

    Report Number
    3004209178-2013-03428
    Event Type
    Malfunction
    Date Received
    March 7, 2013
    Date of Event
    January 25, 2013
    Report Date
    February 13, 2013
    Manufacturer
    MEDTRONIC MED REL MEDTRONIC PUERTO RICO
    Product Code
    LGW
    PMA / PMN Number
    P840001
    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

    PRODUCT ID, 3776-45 LOT# SERIAL# (B)(4), IMPLANTED: 2013 (B)(6), PRODUCT TYPE LEAD PRODUCT ID, 37754 LOT# SERIAL# (B)(4), IMPLANTED: 2013 (B)(6), PRODUCT TYPE RECHARGER PRODUCT ID, 37746 LOT# SERIAL# (B)(4), IMPLANTED: 2013 (B)(6), PRODUCT TYPE PROGRAMMER, PATIENT PRODUCT ID, 3708220 LOT# SERIAL# (B)(4), IMPLANTED: 2013 (B)(6), PRODUCT TYPE EXTENSION PRODUCT ID, 3487A-45 LOT# VA04HZG, IMPLANTED: 2013 (B)(6), PRODUCT TYPE LEAD PRODUCT ID, 3487A-45 LOT# VA04HZG, IMPLANTED: 2013 (B)(6), PRODUCT TYPE LEAD. (B)(4).

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION INDICATED THAT THERE WAS A PREMATURE BATTERY DEPLETION TOGETHER WITH LOW IMPEDANCES OF LESS THAN 50 OHMS OBSERVED ON ELECTRODES 5 AND 7 ON A QUAD LEAD (UNCLEAR, ON WHICH OF THE TWO QUAD LEADS). PROGRAMMING AROUND THESE ELECTRODES WAS DONE AND BATTERY LIFE IMPROVED SOMEWHAT. IT WAS STATED THAT THE PATIENT DID USE AMPLITUDES AROUND 7 AND HAD A GROUP WITH 3 PROGRAMS. PATIENT STATUS AT TIME OF THIS REPORT WAS STATED AS ALIVE WITH NO INJURY/NO ADVERSE EVENT. THERE WERE NO PATIENT SYMPTOMS/INJURIES RELATED TO THIS EVENT.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT WAS CHARGING HER IMPLANTABLE NEUROSTIMULATOR (INS) "MORE THAN EXPECTED." IT WAS FURTHER REPORTED THAT THE PATIENT "HAD TO RECHARGE EVERY NIGHT" AND THAT THIS WAS "MORE FREQUENTLY THAN SHE USED TO." IT WAS ALSO REPORTED THAT THE INS "DIDN'T HOLD A CHARGE." INTERROGATION OF THE PATIENT'S INS REVEALED THE FOLLOWING RECHARGE STATISTICS: "(B)(6) 2013, 2.6HRS, 75%; (B)(6) 2013, 5.1, 100%; (B)(6) 2013, 0.2, 0%; (B)(6) 2013, 4.8, 100%; (B)(6) 2013, 4, 75%; (B)(6) 2013, 2.2, 50%." IMPEDANCE TESTING REVEALED A "SHORT" BETWEEN ELECTRODES 5-7 WITH "NO CAUSE DETERMINED." THE AFOREMENTIONED ELECTRODES WERE REPORTED TO HAVE BEEN "PROGRAMMED AROUND." IT WAS STATED THAT THE PATIENT WAS "RECEIVING EFFECTIVE THERAPY" AT THE TIME OF REPORT. A SUPPLEMENTAL REPORT WILL BE FILED IF ADDITIONAL INFORMATION BECOMES AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    98260 RESTORE SENSOR STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF LGW MEDTRONIC MED REL MEDTRONIC PUERTO RICO 37714

    Patients

    Seq Age Sex Outcome Treatment
    1