BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PRIMEADVANCED

    MDR report key: 3338610 · Received September 10, 2013

    Report

    Report Number
    3004209178-2013-15941
    Event Type
    Injury
    Date Received
    September 10, 2013
    Date of Event
    October 1, 2009
    Report Date
    October 21, 2016
    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: PRODUCT ID 3998, LOT# V113343, IMPLANTED: 2009-(B)(6), PRODUCT TYPE LEAD, PRODUCT ID 3708360, SERIAL# (B)(4), IMPLANTED: 2009-(B)(6), PRODUCT TYPE EXTENSION, PRODUCT ID 37083-60, SERIAL# (B)(4), IMPLANTED: 2009-(B)(6), PRODUCT TYPE EXTENSION. (B)(4).

    Additional Manufacturer Narrative · 1

    THE MAIN COMPONENT OF THE SYSTEM AND OTHER APPLICABLE COMPONENTS ARE: PRODUCT ID: 3998, LOT# V113343, IMPLANTED: (B)(6) 2009, PRODUCT TYPE: LEAD .PRODUCT ID: 3708360, SERIAL# (B)(4), IMPLANTED: (B)(6) 2009, PRODUCT TYPE: EXTENSION. PRODUCT ID: 37083-60, SERIAL# (B)(4), IMPLANTED: (B)(6) 2009, PRODUCT TYPE: EXTENSION. A GOOD FAITH EFFORT WILL BE MADE TO OBTAIN THE APPLICABLE INFORMATION RELEVANT TO THE REPORT. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT HAD SOME FORM OF TRAUMA FROM A CAR ACCIDENT ABOUT 9 MONTHS AFTER IMPLANT. THE LEADS MOVED A LITTLE BIT DUE TO THE ACCIDENT AND 2 ELECTRODES WERE OUT SO THE PATIENT HAD TO BE REPROGRAMMED AROUND IT, THOUGH THE COVERAGE WAS NOT AS GOOD. IT WAS NOTED THAT THE PATIENT HAD A THIRD PROGRAM ADDED ON THE DAY OF THE REPORT BECAUSE OF ISSUES WITH STIMULATION COVERAGE. THE REPORTER NOTED THAT THE BATTERY LIFE WAS ACCESSED FOR FURTHER REPLACEMENT. IT WAS NOTED THAT THE PATIENT ALREADY HAD IT FOR 4 YEARS WITH THE BATTERY VOLTAGE AT 3.025V, SO THE PATIENT HAD FURTHER TIME LEFT ON THE BATTERY. ADDITIONAL INFORMATION HAS BEEN REQUESTED, BUT IT WAS NOT AVAILABLE AS OF THE DATE OFF THIS REPORT.

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION RECEIVED REPORTED THAT THE PATIENT WAS REPROGRAMMED AND WAS DOING WELL.

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION RECEIVED FROM THE PATIENT ON (B)(6) 2016 REPORTED THAT SHE WAS IN A MINOR FENDER BENDER ABOUT 7 YEARS AGO BUT HER LEAD PADDLES HAD MOVED. THE PATIENT STATED THEY BASICALLY HAD TO WAIT UNTIL THE BATTERY WENT DEAD AND WHEN THEY REPLACED THE BATTERY THEY WENT IN AND REPLACED THE LEAD PADDLES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    453228 PRIMEADVANCED STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF LGW MEDTRONIC MED REL MEDTRONIC PUERTO RICO 37702

    Patients

    Seq Age Sex Outcome Treatment
    1 00038 YR Required Intervention