BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PRIMEADVANCED

    MDR report key: 7367646 · Received March 23, 2018

    Report

    Report Number
    3004209178-2018-05664
    Event Type
    Injury
    Date Received
    March 23, 2018
    Date of Event
    November 15, 2013
    Report Date
    April 16, 2018
    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
    FL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    CONTINUATION OF CONCOMITANT MEDICAL PRODUCTS: PRODUCT ID: 3550-39, LOT# N230568, IMPLANTED: (B)(6) 2009, EXPLANTED: (B)(6) 2013, PRODUCT TYPE: ACCESSORY. PRODUCT ID: 3998, LOT# V279273, IMPLANTED: (B)(6) 2009, EXPLANTED: (B)(6) 2013, PRODUCT TYPE: LEAD. INFORMATION REFERENCES THE MAIN COMPONENT OF THE SYSTEM. OTHER RELEVANT DEVICE(S) ARE: PRODUCT ID: 3998, SERIAL/LOT #: (B)(4), UBD: (B)(6) 2013, UDI#: (B)(4). 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.

    Description of Event or Problem · 1

    INFORMATION WAS RECEIVED FROM A CONSUMER CONCERNING A PATIENT WITH AN IMPLANTABLE NEUROSTIMULATOR (INS) FOR SPINAL PAIN. IT WAS REPORTED THAT THE PATIENT HAD HER THIRD STIMULATOR PLACED IN (B)(6) 2013 AND THEY MOVED THE PADDLES BECAUSE THE WIRES FROM HER SECOND STIMULATOR WERE DETERIORATING. NO ADDITIONAL COMPLICATIONS WERE REPORTED/ANTICIPATED. OMITTED INFORMATION RELATED TO (B)(4) ¿ LOSS OF STIM, PAIN, HANDS BLUE AND CURLING.

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION WAS RECEIVED FROM A HEALTHCARE PROFESSIONAL (HCP) ON 2018-MAR-26. IT WAS REPORTED THAT THE LEADS HAD HIGH IMPEDANCES WHICH INDICATED THAT THEY WERE FRACTURED. AT THE SAME TIME, THE BATTERY WAS REACHING THE END OF ITS SERVICE (EOS). THE SYMPTOMS THE PATIENT EXPERIENCED RELATED TO THIS ISSUE WERE RETURN OF COMPLEX REGIONAL PAIN SYNDROME (CRPS) PAIN, HAND CLENCHING, AND TEMPERATURE/COLOR CHANGES. THE HCP THEN NOTED THAT THERE WAS NO SPECIFIC INCIDENT THAT LED TO THE LEADS DETERIORATING BUT THE LEADS WERE IN THE CERVICAL SPINE WHICH WERE MORE PRONE TO FRACTURE DUE TO NECK MOVEMENT. THERE WERE NO FURTHER COMPLICATIONS REPORTED OR ANTICIPATED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    210273 PRIMEADVANCED STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF LGW MEDTRONIC MED REL MEDTRONIC PUERTO RICO 37702

    Patients

    Seq Age Sex Outcome Treatment
    1 75 YR Required Intervention