BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ITREL 4

    MDR report key: 5696594 · Received June 2, 2016

    Report

    Report Number
    3004209178-2016-10798
    Event Type
    Injury
    Date Received
    June 2, 2016
    Date of Event
    May 7, 2016
    Report Date
    July 28, 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
    MO, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    ANALYSIS OF THE NEUROSTIMULATOR, SERIAL #(B)(4), FOUND NO ANOMALY. ANALYSIS OF THE LEAD, SERIAL # (B)(4), FOUND THE LEAD BODY/CONDUCTOR BROKEN AT TWIST LOCK ANCHOR SITE. 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.

    Additional Manufacturer Narrative · 1

    ANALYSIS RESULTS WERE NOT AVAILABLE AT THE TIME OF THIS REPORT. A FOLLOW-UP REPORT WILL BE SENT WHEN ANALYSIS IS COMPLETED. 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.

    Additional Manufacturer Narrative · 1

    (B)(4).

    Additional Manufacturer Narrative · 1

    INFORMATION REFERENCES THE MAIN COMPONENT OF THE SYSTEM AND OTHER APPLICABLE COMPONENTS ARE: PRODUCT ID: 3888, SERIAL# (B)(4), PRODUCT TYPE: LEAD.

    Additional Manufacturer Narrative · 1

    IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION RECEIVED REPORTED THAT THE PATIENT'S IMPLANTABLE NEUROSTIMULATOR (INS) WAS REMOVED DUE TO NORMAL BATTERY DEPLETION. THE PRODUCT WAS RETURNED TO THE MANUFACTURER.

    Description of Event or Problem · 1

    INFORMATION WAS RECEIVED FROM A PATIENT WHO WAS IMPLANTED WITH A NEUROSTIMULATOR FOR SPINAL PAIN VIA A MANUFACTURER REPRESENTATIVE. IT WAS REPORTED THAT THE PATIENT WAS MOVING TO LIE DOWN ON HER COUCH WHEN SHE SUDDENLY LOST THERAPY ON (B)(6) 2016. THE PATIENT WAS PROGRAMMED ON 0 AND 3 AND WHEN SHE CAME IN, THERE WAS A THERAPY IMPEDANCE OF 2883 OHMS AND 2066 MILLIAMPS. THE MANUFACTURER REPRESENTATIVE TRIED REPROGRAMMING ON 1 & 3 AND 2 & 3 AND INCREASED THE AMPLITUDE PAST 8 VOLTS AND THE PATIENT WAS UNABLE TO FEEL ANYTHING. THERE WAS AN IMPEDANCE CHECK AT 3 VOLTS AND THE CONTACTS MEASURED AS FOLLOWS FOR INDIVIDUAL CONTACTS: C0 20620 OHMS, C1 21623 OHMS, C2 22084 OHMS, C3 22084 OHMS. AN IMPEDANCE CHECK AT 3 VOLTS AND THE CONTACTS MEASURED AS FOLLOWS FOR THE FOLLOWING PAIRS: C1-0 2209 OHMS, C1-2 1700 OHMS, C1-3 2886 OHMS, C2-0 3110 OHMS, AND C2-3 1871 OHMS. EVERYTHING WITH THE PATIENT'S POCKET LOOKED OKAY. ADDITIONAL INFORMATION RECEIVED ON (B)(6) 2016 INDICATED THAT NO INTERVENTIONS HAD BEEN TAKEN TO RESOLVE THE LOSS OF THERAPY. THE CAUSE OF THE LOSS OF THERAPY HAD NOT YET BEEN DETERMINED, AND THE PATIENT WAS NOT RECEIVING THERAPY AT THAT TIME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    350571 ITREL 4 STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF LGW MEDTRONIC MED REL MEDTRONIC PUERTO RICO 37703

    Patients

    Seq Age Sex Outcome Treatment
    1 86 YR Required Intervention