BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PRIMEADVANCED

    MDR report key: 3354049 · Received September 18, 2013

    Report

    Report Number
    3004209178-2013-16438
    Event Type
    Injury
    Date Received
    September 18, 2013
    Date of Event
    May 1, 2013
    Report Date
    September 9, 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
    NV, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    CONCOMITANT PRODUCTS: PRODUCT ID 39565-65, SERIAL # (B)(4), IMPLANTED: (B)(6) 2009, PRODUCT TYPE LEAD; PRODUCT ID 37743, SERIAL # (B)(4), PRODUCT TYPE PROGRAMMER, PATIENT; PRODUCT ID 3550-41, LOT # N172222, IMPLANTED: (B)(6) 2009, PRODUCT TYPE ACCESSORY. (B)(4).

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION RECEIVED REPORTED THE PATIENT¿S IMPLANTABLE NEUROSTIMULATOR WAS REPLACED. IT WAS NOTED THE PATIENT WAS SEEN BY A MANUFACTURING REPRESENTATIVE AT THEIR FOLLOW UP APPOINTMENT ON 2013-(B)(6) AND THE PATIENT WAS SATISFIED WITH THE OUTCOME.

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION RECEIVED REPORTED THE REVISION SURGERY WAS CANCELLED BY THE PATIENT'S HEALTHCARE PROFESSIONAL DUE TO AN EMERGENCY. IT WAS NOTED THAT A NEW REVISION SURGERY HAD NOT BE SCHEDULED.

    Description of Event or Problem · 1

    FOLLOW UP INFORMATION REPORTED THAT THE PATIENT WAS WAITING FOR A SURGERY DATE FROM THEIR PHYSICIAN. IT WAS NOTED, THAT AS OF (B)(6) 2013, THAT THE PATIENT HAD APPROXIMATELY 30% BATTERY LIFE LEFT IN THEIR IMPLANTABLE NEUROSTIMULATOR (INS) AND THAT IMPEDANCES VALUES WERE NORMAL. THE PATIENT STATED THAT THEY WERE HAPPY WITH THEIR THERAPY COVERAGE. ADDITIONAL FOLLOW UP INFORMATION RECEIVED 4 DAYS LATER REPORTED THAT THE PATIENT WAS SCHEDULED FOR (B)(6) 2013 FOR A INS BATTERY CHANGE PROCEDURE. IF ADDITIONAL INFORMATION IS RECEIVED, A FOLLOW UP REPORT WILL BE SENT.

    Description of Event or Problem · 1

    IT WAS INITIALLY REPORTED THAT AN ELECTIVE REPLACEMENT INDICATOR (ERI) WAS DISPLAYED ON THE PATIENT PROGRAMMER FOR ¿ABOUT A MONTH.¿ IT WAS NOTED THAT THE STIMULATION WAS ON ¿ALL THE TIME¿ AND HELPED THE PATIENT¿S NERVE PROBLEMS. THE PATIENT FELT IT WAS TIME FOR THE DEVICE TO BE REPLACED. IT WAS NOTED THE PATIENT INQUIRED AS TO THE MEANING OF ERI. ADDITIONAL INFORMATION RECEIVED 2.5 MONTHS LATER REPORTED THE PATIENT RECEIVED AN ERI MESSAGE ABOUT 6 MONTHS AGO AND HIS BATTERY IS GOING TO EXPIRE ANY DAY NOW. THE PATIENT LAST TALKED TO HIS DOCTOR¿S OFFICE ABOUT 3-4 WEEKS AGO. HE WAS SCHEDULED TO HAVE HIS DEVICE REPLACED ON SEPTEMBER 3 BUT IT WAS CANCELED BECAUSE THAT SURGICAL FACILITY WAS NO LONGER DOING STIMULATION PROCEDURES. THE PATIENT COULD PHYSICALLY FEEL HIS STIMULATION FADING AND HE HAD TO TURN HIS IMPLANT UP TO 8-9 V AND THEN STIMULATION WOULD ALL OF A SUDDEN GO UP OR GO BACK TO ITS INTENDED FUNCTION. THE PATIENT¿S REPLACEMENT PROCEDURE WAS MOVED TO A LATER DATE BUT HE¿D BEEN UNABLE TO GET IN TOUCH WITH ANYONE TO CONFIRM THIS. ADDITIONAL INFORMATION HAS BEEN REQUESTED BUT WAS NOT AVAILABLE AS OF THE DATE OF THIS REPORT; A FOLLOW-UP REPORT WILL BE SENT IF INFORMATION BECOMES AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    470096 PRIMEADVANCED STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF LGW MEDTRONIC MED REL MEDTRONIC PUERTO RICO 37702

    Patients

    Seq Age Sex Outcome Treatment
    1 00052 YR Required Intervention