BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RESTORE ADVANCED

    MDR report key: 3113784 · Received May 15, 2013

    Report

    Report Number
    3004209178-2013-07702
    Event Type
    Malfunction
    Date Received
    May 15, 2013
    Report Date
    April 29, 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

    CONCOMITANT PRODUCTS: PRODUCT ID 3487A-45, LOT# J0519613V, IMPLANTED: (B)(6) 2007, PRODUCT TYPE LEAD; PRODUCT ID 377845, LOT# V019174, IMPLANTED: (B)(6) 2007, PRODUCT TYPE LEAD; PRODUCT ID 3708140, SERIAL# (B)(4), IMPLANTED: (B)(6) 2007, PRODUCT TYPE EXTENSION; PRODUCT ID 3708260, SERIAL# (B)(4), IMPLANTED: (B)(6) 2007, PRODUCT TYPE EXTENSION; PRODUCT ID 3487A-45, LOT# V015146, IMPLANTED: (B)(6) 2007, PRODUCT TYPE LEAD. (B)(4).

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE MANUFACTURER REPRESENTATIVE CONDUCTED A PHYSICIAN MODE RECHARGE (PMR) FOR AN OVERDISCHARGED BATTERY. FOLLOWING THE RECHARGE THE PHYSICIAN PROGRAMMER INDICATED THAT THE BATTERY NEEDED TO BE CHARGED. IT WAS NOTED THAT THE INS NEEDED TO BE CHARGED TO 25% FULL BEFORE IT COULD BE INTERROGATED WITH THE PHYSICIAN PROGRAMMER. THE REPRESENTATIVEPLANNED TO LET THE PATIENT RECHARGE FOR AN HOUR BEFORE RE-INTERROGATING. IT WAS LATER REPORTED THAT THE PATIENT EXPERIENCED TELEMETRY ISSUES AND AN INS OVERDISCHARGE WAS SUSPECTED. THE PATIENT HAD NOT BEEN USING STIMULATION AS IT WAS UNSATISFACTORY. IT WAS NOTED THAT THE PATIENT HAD BEEN GOING TO A CLINIC THAT WAS CLOSING SO THERE WAS AN INTERRUPTION IN HER CARE. IT HAD BEEN ABOUT 7 MONTHS SINCE THE PATIENT LAST FELT STIMULATION. A MANUFACTURER REPRESENTATIVE CONDUCTED AN HOUR LONG PHYSICIAN RECHARGE MODE AND THE INS STILL DID NOT RESPOND. ADDITIONAL INFORMATION HAS BEEN REQUESTED, BUT WAS NOT AVAILABLE AS OF THE DATE OF THIS REPORT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    214770 RESTORE ADVANCED STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF LGW MEDTRONIC MED REL MEDTRONIC PUERTO RICO 37713

    Patients

    Seq Age Sex Outcome Treatment
    1