BEUDAMED
    FDA Adverse Event Injury Summary report: N

    RESTORE

    MDR report key: 3887105 · Received June 20, 2014

    Report

    Report Number
    3004209178-2014-11888
    Event Type
    Injury
    Date Received
    June 20, 2014
    Report Date
    May 29, 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

    (B)(4)

    Additional Manufacturer Narrative · 1

    (B)(4).

    Additional Manufacturer Narrative · 1

    CONCOMITANT MEDICAL PRODUCTS: PRODUCT ID 355029, LOT# N063026, IMPLANTED: (B)(6) 2006, PRODUCT TYPE: ACCESSORY; PRODUCT ID 37742, SERIAL# (B)(4), IMPLANTED: (B)(6) 2006, PRODUCT TYPE: PROGRAMMER, PATIENT; PRODUCT ID 3708360, SERIAL# (B)(4), IMPLANTED: (B)(6) 2006, PRODUCT TYPE: EXTENSION; PRODUCT ID 37752, SERIAL# (B)(4), IMPLANTED: (B)(6) 2006, PRODUCT TYPE: RECHARGER; PRODUCT ID 3887-33, LOT# J0526949V, IMPLANTED: (B)(6) 2006, PRODUCT TYPE: LEAD; PRODUCT ID 3887-33, LOT# J0526949V, IMPLANTED: (B)(6) 2006, PRODUCT TYPE: LEAD. (B)(4).

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION RECEIVED REPORTED THE PATIENT WAS DOING FINE, AND EXPERIENCED ¿NORMAL BATTERY DEPLETION.¿

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT WAS NEAR ELECTIVE REPLACEMENT INDICATOR (ERI). THE PATIENT MAY BE GETTING A BATTERY REVISION SUSPECTED TO ONLY BE DUE TO END OF SERVICE (EOS). THE MANUFACTURER REPRESENTATIVE WAS MEETING THE PATIENT ON THE DAY OF THE REPORT. IT WAS FURTHER REPORTED THAT THE PATIENT WAS GOING TO GET THEIR SYSTEM REMOVED AND A TRIAL SYSTEM WITH TWO NEW LEADS PUT IN. THE PATIENT FELT LIKE THEY NEVER GOT THE APPROPRIATE COVERAGE WITH THE ORIGINAL IMPLANT. IT WAS FURTHER REPORTED THAT THE OLD SYSTEM WAS GOING TO BE EXPLANTED ON (B)(6) AND THE PATIENT WOULD DO A NEW TRIAL. THERE WAS NOTHING WRONG WITH THE OLD SYSTEM, BUT IT WAS DETERMINED THAT THE LEAD WAS NOT CORRECTLY PLACED. THE PATIENT WAS COMING UP ON THE END OF BATTERY LIFE SO THEY DECIDED TO REPLACE IT WITH A NEW SYSTEM AFTER THE TRIAL. IT WAS FURTHER REPORTED THAT THEY WERE PLANNING TO LEAD A QUAD LEAD IN PLACE AND ADD A NEW LEAD TO ADDRESS DISEASE PROGRESSION. THE STIMULATOR AND EXTENSION WERE GOING TO BE REMOVED THE DAY AFTER THE REPORT AND THE PATIENT WAS GOING TO BE TRIALED WITH TWO NEW LEADS TO GET A LARGER AREA OF STIMULATION COVERAGE. ADDITIONAL INFORMATION HAS BEEN REQUESTED, BUT WAS NOT AVAILABLE AS OF THE DATE OF THIS REPORT. IF ADDITIONAL INFORMATION IS RECEIVED, A FOLLOW UP REPORT WILL BE SENT.

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION RECEIVED REPORTED THAT THE PATIENT HAD A NEW DEVICE PUT IN 2014 BECAUSE THE LEAD FROM THE INITIAL IMPLANT MALFUNCTIONED SO THE WHOLE SYSTEM WAS REPLACED.

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION RECEIVED REPORTED THAT ONE OF THE LEADS HAD NEVER BEEN WORKING RIGHT. NO FOLLOW-UP WAS REQUIRED AS THIS WAS A HISTORICAL EVENT AND THE SYSTEM HAD ALREADY BEEN REPLACED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    363349 RESTORE STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF LGW MEDTRONIC MED REL MEDTRONIC PUERTO RICO 37711

    Patients

    Seq Age Sex Outcome Treatment
    1 00063 YR Required Intervention