BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PRIMEADVANCED

    MDR report key: 7957001 · Received October 11, 2018

    Report

    Report Number
    3004209178-2018-22829
    Event Type
    Malfunction
    Date Received
    October 11, 2018
    Report Date
    January 25, 2019
    Manufacturer
    MEDTRONIC MED REL MEDTRONIC PUERTO RICO
    Product Code
    LGW
    PMA / PMN Number
    P840001
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    OTHER RELEVANT DEVICE(S) ARE: PRODUCT ID: 3487A-33, SERIAL/LOT #:(B)(4), UBD: 01-FEB-2011, UDI#: (B)(4). PRODUCT ID: 748925, SERIAL/LOT #: (B)(4), UBD: 11-APR-2010, UDI#: (B)(4). IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Additional Manufacturer Narrative · 1

    CONCOMITANT MEDICAL PRODUCTS: PRODUCT ID: 3487A-33, LOT# V020693, IMPLANTED: (B)(6) 2007, EXPLANTED: (B)(6) 2018, PRODUCT TYPE: LEAD. PRODUCT ID: 748925, SERIAL# (B)(4), IMPLANTED: (B)(6) 2007, EXPLANTED: (B)(6) 2018, PRODUCT TYPE: EXTENSION. PRODUCT ID: 74001, LOT# N245037, PRODUCT TYPE: ADAPTER. A SUPPLEMENTAL REPORT WILL BE SUBMITTED WHEN ANALYSIS RESULTS ARE AVAILABLE. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Additional Manufacturer Narrative · 1

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

    Additional Manufacturer Narrative · 1

    PRODUCT ID: 3487A-33, LOT# V020693, IMPLANTED: (B)(6) 2007, EXPLANTED: (B)(6) 2018, PRODUCT TYPE: LEAD; PRODUCT ID: 748925, SERIAL# (B)(4), IMPLANTED: (B)(6) 2007, EXPLANTED: (B)(6) 2018, PRODUCT TYPE: EXTENSION; PRODUCT ID: 74001, LOT# N245037, PRODUCT TYPE: ADAPTER. ANALYSIS OF THE LEAD V020693 FOUND THE OUTER INSULATION OF THE LEAD WAS SEPARATED IN THE BODY OF THE LEAD AT A BUTT JOINT AT THE PROXIMAL END OF THE LEAD; CONSISTENT WITH EXPLANT DAMAGE. THE FUNCTIONAL TEST SHOWED: #0-OPEN #1- 103.3 OHMS #2 ¿ 104.5 OHMS #3 ¿ 98.9 OHMS NO SHORTS (DRY CONDITIONS). ANALYSIS OF THE EXTENSION (B)(4) FOUND THE EXTENSION BODY CONDUCTOR WAS BROKEN (OVERSTRESS/DAMAGED); CONSISTENT WITH EXPLANT DAMAGE.. #0-3.1 OHMS #1- 2.9 OHMS #2 ¿ INTERMITTENT #3 ¿ 1.6 OHMS NO SHORTS (DRY CONDITIONS). THE SYSTEM FUNCTIONAL TEST SHOWED #0-OPEN #1- 129.7 OHMS #2 ¿ INTERMITTENT #3 ¿ 124.9 OHMS NO SHORTS (DRY CONDITIONS). EVALUATION METHOD, RESULTS AND CONCLUSION CODE APPLY TO BOTH LEAD AND EXTENSION. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Description of Event or Problem · 1

    INFORMATION WAS RECEIVED FROM A MANUFACTURER REPRESENTATIVE REGARDING A PATIENT WHO WAS IMPLANTED WITH A NEUROSTIMULATOR FOR OTHER CHRONIC/INTRACT PAIN (TRUNK/LIMBS), SPINAL PAIN, FAILED BACK SURGERY SYNDROME, COMPLEX REG PAIN SYNDROME TYPE I, AND FAILED BACK SYNDROME - OTHER. IT WAS REPORTED THAT THE PATIENT WAS HAVING A REVISION DUE TO NORMAL IMPLANTABLE NEUROSTIMULATOR (INS) DEPLETION. THEY COMPLETELY REMOVED THE LEAD AND INS FOR THE NEW IMPLANT TO BE MRI CONDITIONAL. BEFORE THE PROCEDURE THE PATIENT WAS RECEIVING GOOD THERAPY AND BENEFIT. IT WAS REPORTED THAT THE LEAD PROXIMAL END WAS DAMAGED AND HAD NO INSULATION. THERE WAS SEPARATION OF INSULATION AT THE PROXIMAL ELECTRODE CONTACTS. THE MANUFACTURER REPRESENTATIVE PLANNED TO RETURN THE EXPLANTED DEVICES FOR ANALYSIS. NO FURTHER COMPLICATIONS WERE REPORTED.

    Description of Event or Problem · 1

    IT WAS CONFIRMED THAT THE EXPLANT OCCURRED ON (B)(6) 2018. IT WAS STATED THAT THE SYSTEM HAD WORKED WITH NO PROBLEMS AND THE FULL SYSTEM WAS CHANGED OUT TO PROVIDE MRI COMPATIBILITY. DURING THE REMOVAL, IT WAS DISCOVERED THAT THE LEAD COVERING WAS MISSING. THE PATIENT RECOVERED WITHOUT SEQUELA. NO FURTHER COMPLICATIONS WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    798382 PRIMEADVANCED STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF LGW MEDTRONIC MED REL MEDTRONIC PUERTO RICO 37702

    Patients

    Seq Age Sex Outcome Treatment
    1