BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PRIMEADVANCED

    MDR report key: 4173833 · Received October 15, 2014

    Report

    Report Number
    3004209178-2014-19732
    Event Type
    Injury
    Date Received
    October 15, 2014
    Report Date
    September 26, 2014
    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
    CO, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    CONCOMITANT MEDICAL PRODUCTS: PRODUCT ID 39565-65, SERIAL# (B)(4), IMPLANTED: (B)(6) 2012, PRODUCT TYPE: LEAD; PRODUCT ID 97740, SERIAL# (B)(4), PRODUCT TYPE: PROGRAMMER, PATIENT. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT WAS UNABLE TO GET ANY STIMULATION COVERAGE WHERE THEY NEEDED IT (LOW BACK, DOWN LEFT LEG TO FOOT ¿ FOOT PAIN WAS THE WORST) FROM THEIR IMPLANTABLE NEUROSTIMULATOR (INS) THAT WAS NOT IN THE ABDOMINAL REGION. IMPEDANCE TESTING SHOWED HIGH IMPEDANCES (>10,000 OHMS) ON ELECTRODES #8, 9, 10, 12, 13, 14, AND 15 WITH ALL OTHER CONTACTS NOTED TO BE WITHIN NORMAL RANGE. THE MANUFACTURER¿S REPRESENTATIVE WAS UNABLE TO USE THE AFFECTED ELECTRODES FOR PROGRAMMING AND WHEN THEY TRIED TO USE THE ELECTRODES WITH NORMAL IMPEDANCES THEY COULD NOT GET STIMULATION FOR THE PATIENT WHERE THEY NEEDED IT. THE PATIENT WAS SENT HOME WITH THE INS OFF AND AT 0.0 VOLTS TO PRESERVE THE BATTERY LIFE. IT WAS REPORTED THAT A LEAD WAS PLANNED AND THAT THE PATIENT WAS TO BE CONTACTED BY THEIR PHYSICIAN¿S OFFICE TO SCHEDULE AN APPOINTMENT WITH THE SURGEON FOR CONSULTATION/DISCUSSION TO REPLACE OR REVISE THE LEAD. THE PATIENT STATUS AT THE TIME OF REPORT WAS NOTED AS ¿ALIVE ¿ NO INJURY¿. THERE WERE NO FURTHER DETAILS, INTERVENTIONS OR OUTCOME REPORTED REGARDING THIS EVENT. FURTHER FOLLOW-UP IS BEING CONDUCTED TO OBTAIN THIS INFORMATION. IF ADDITIONAL INFORMATION IS RECEIVED, A FOLLOW-UP REPORT WILL BE SENT.

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION RECEIVED REPORTED A REPLACEMENT HAD NOT BEEN SCHEDULED YET FOR THE PATIENT. THERE WERE NO ISSUES THAT THE MAN UFACTURER REPRESENTATIVE (REP) WAS AWARE OF THAT COULD HAVE CAUSED THE HIGH IMPEDANCES. AS FAR AS THE REP KNEW, THE PATIENT WORE THE STIMULATOR AT VERY LOW AMPLITUDES AND IT DIDN¿T PROVE TO BE VERY BENEFICIAL TO HIM AT THIS POINT. THE PATIENT DID MEET WITH THE PHYSICIAN TO CONSULT FOR A REVISION/REPLACEMENT, THE SURGERY JUST HAD NOT BEEN SCHEDULED DUE TO INSURANCE COMPLICATIONS. NO OUTCOME OR INTERVENTIONS WERE REPORTED REGARDING THIS EVENT. FURTHER FOLLOW-UP IS BEING CONDUCTED TO OBTAIN THIS INFORMATION. IF ADDITIONAL FOLLOW-UP IS RECEIVED, A FOLLOW-UP REPORT WILL BE SENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    655616 PRIMEADVANCED STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF LGW MEDTRONIC MED REL MEDTRONIC PUERTO RICO 37702

    Patients

    Seq Age Sex Outcome Treatment
    1 00061 YR Required Intervention