BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PRIMEADVANCED

    MDR report key: 3102180 · Received May 9, 2013

    Report

    Report Number
    3004209178-2013-07410
    Event Type
    Injury
    Date Received
    May 9, 2013
    Report Date
    November 14, 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
    IN, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Additional Manufacturer Narrative · 1

    PRODUCT ID: 3550-39, LOT# N342979, IMPLANTED: (B)(60 2012, PRODUCT TYPE: ACCESSORY. PRODUCT ID: 3 778-60, SERIAL# (B)(4), IMPLANTED: (B)(6) 2012, PRODUCT TYPE: LEAD. PRODUCT ID: 3778-60, SERIAL# (B)(4), IMPLANTED: (B)(6) 2012, PRODUCT TYPE: LEAD. PRODUCT ID: 37744, SERIAL# (B)(4), PRODUCT TYPE: PROGRAMMER. (B)(4).

    Additional Manufacturer Narrative · 1

    ANALYSIS OF THE IMPLANTABLE NEUROSTIMULATOR (SERIAL #(B)(4)) FOUND NO ANOMALY. ANALYSIS OF THE 1X8 COMPACT LEAD (SERIAL # (B)(4)) FOUND THAT THE STIM LEAD CONDUCTOR WAS BROKEN AT THE TITAN ANCHOR SITE. THE CONDUCTORS WERE BROKEN 22.6 CM FROM THE DISTAL END. ANALYSIS OF THE 1X8 COMPACT LEAD (SERIAL #(B)(4)) FOUND THAT THE STIM LEAD CONDUCTOR WAS BROKEN AT THE TITAN ANCHOR SITE. THE CONDUCTORS WERE BROKEN 23.2 CM FROM THE DISTAL END.

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION RECEIVED REPORTED THAT THE CAUSE OF THE EVENT WAS A PATIENT FALL ON (B)(6) 2013. THE EVENT WAS ATTRIBUTED TO THE LEAD AND ONLY THREE OF SIXTEEN CONTACTS WERE FUNCTIONAL. AN OPERATING ROOM (OR) DATE WAS PENDING AS THE PATIENT REQUESTED FOR EXPLANT. THE PATIENT WAS REPROGRAMMED WITH THE THREE FUNCTIONAL CONTACTS AND OBTAINED PARASTHESIA IN THE DISTRIBUTION OF PAIN. PRIOR TO THIS THE PATIENT HAD A LOSS OF COVERAGE. HOSPITALIZATION AS NOT REQUIRED AND THE PATIENT OUTCOME WAS NOTED AS A NON-SERIOUS INJURY OR ILLNESS.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT LOST STIMULATION THE NIGHT PRIOR TO THE REPORT. IT WAS NOTED THAT THE PATIENT INCREASED HIS STIMULATION "CLEAR UP, BUT NOTHING." IT WAS NOTED THAT THE PATIENT DID "NOT RECALL AN END OF SERVICE (EOS) MESSAGE ON HIS PROGRAMMER." IT WAS FURTHER NOTED THAT THE PATIENT HAD AN APPOINTMENT WITH THE MANUFACTURING REPRESENTATIVE THE DAY AFTER THE REPORT. IT WAS NOTED THAT THE MANUFACTURING REPRESENTATIVE CHECKED THE IMPEDANCES ON THE DEVICE AND FOUND A "FEW ELECTRODES OUT OF RANGE." IT WAS NOTED THAT THE PATIENT'S DEVICE WAS REPROGRAMMED AND PATIENT WAS RECEIVING "GOOD STIMULATION." IT WAS FURTHER NOTED THAT THE PATIENT FELL A "FEW WEEKS" PRIOR TO THE REPORT.

    Description of Event or Problem · 1

    FOLLOW UP INFORMATION REPORTED THAT ANY INTERVENTIONS (ANY SURGICAL REVISION) HAD NOT BEEN SCHEDULED YET AS INSURANCE ISSUES WERE STILL BEING WORKED OUT. 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 AND HIS WIFE WERE FRUSTRATED. THE PATIENT JUST WANTED THE DEVICE EXPLANTED AND THE DOCTOR AGREED TO EXPLANT.

    Description of Event or Problem · 1

    FOLLOW UP INFORMATION RECEIVED REPORTED THAT HIGH IMPEDANCES WERE SEEN (>10,000 OHMS) ON THE LEADS OF THE IMPLANTABLE NEUROSTIMULATOR (INS) SYSTEM. IT WAS NOTED THAT THE PATIENT HAD BEEN REPROGRAMMED 2 TIMES. IN ADDITION, IT WAS REPORTED THAT THIS TIME THE PATIENT WAS GETTING THERAPY UP UNTIL A COUPLE OF DAYS AGO. IT WAS ALSO REPORTED THAT THE PATIENT HAD A ¿HARD¿ FALL IN THE SPRING AND RECEIVED INTERMITTENT THERAPY. WHEN THE PATIENT BENT IN DIFFERENT POSITIONS THE IMPEDANCES CHANGED. SPECIFICALLY, SOME OF THE ELECTRODES WERE OUT OF RANGE BUT WHEN THE PATIENT BENT FORWARD ALL OF THE ELECTRODES WERE OUT OF RANGE (>10,000 OHMS). THE IMPEDANCES WERE NOTED TO VARY WITH THE PATIENT¿S POSITION. NOTABLY, WHEN THE PATIENT LEANED BACK THE PATIENT THEY WOULD GET STIMULATION BUT IT THE SITTING POSITION ELECTRODE #4 WAS WITHIN NORMAL LIMITS. WHEN THE CHANGING THE REFERENCE ELECTRODE, ELECTRODES #0 AND 4 WERE WITHIN NORMAL LIMITS. THE PATIENT WAS NO LONGER IN THE BELLY AFTER REPROGRAMING. THE PATIENT WAS BEING REFERRED TO THEIR PHYSICIAN FOR FURTHER FOLLOW UP AND A POSSIBLE REVISION. THE PATIENT STATUS AT THE TIME OF THE REPORT WAS ALIVE WITH NO INJURY. IF ADDITIONAL INFORMATION I S RECEIVED A FOLLOW UP REPORT WILL BE SENT

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    203033 PRIMEADVANCED STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF LGW MEDTRONIC MED REL MEDTRONIC PUERTO RICO 37702

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention