BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PRIMEADVANCED

    MDR report key: 4993108 · Received August 11, 2015

    Report

    Report Number
    3004209178-2015-15818
    Event Type
    Malfunction
    Date Received
    August 11, 2015
    Date of Event
    July 17, 2015
    Report Date
    October 23, 2020
    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
    TX, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Additional Manufacturer Narrative · 1

    CONCOMITANT MEDICAL PRODUCTS: PRODUCT ID: 3776-75, SERIAL# (B)(4), IMPLANTED: (B)(6) 2010, PRODUCT TYPE: LEAD. PRODUCT ID: 37752, SERIAL# (B)(4), IMPLANTED: (B)(6) 2006, PRODUCT TYPE: RECHARGER. PRODUCT ID: 37742, SERIAL#(B)(4), IMPLANTED: (B)(6) 2008, PRODUCT TYPE: PROGRAMMER, PATIENT. (B)(4).

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION RECEIVED FROM THE PATIENT REPORTED THAT THEY HAD CONTACTED THEIR PAIN MANAGEMENT PHYSICIAN THE SAME DAY THEY NOTIFIED THAT THEIR STIMULATOR WAS NO LONGER WORKING. THEY HAD AN UPCOMING CONSULTATION SCHEDULED ON (B)(6) 2015. THIS APPOINTMENT WAS FOR AN AXILLARY NERVE BLOCK WITH SEDATION AND SECONDARILY TO DISCUSS REPLACING THEIR IMPLANTABLE NEUROSTIMULATOR (INS). THEY HAD NO ACCESS TO PAIN RELIEF FOR THEIR CHRONIC REGIONAL PAIN SYNDROME OTHER THAN PRESCRIPTION MEDICATION WHICH DID NOT WORK WELL FOR THEM. IF ADDITIONAL INFORMATION S RECEIVED, A FOLLOW-UP REPORT WILL BE SENT.

    Description of Event or Problem · 1

    IT WAS REPORTED BY THE PATIENT THAT THERE WAS AN ELECTIVE REPLACEMENT INDICATOR (ERI) THAT OCCURRED ON THEIR IMPLANTABLE NEUROSTIMULATOR (INS). THEY HAD A SUDDEN LOSS OF STIMULATION SENSATION AND A LOSS OF THERAPEUTIC EFFECT (NOT HELPING THEIR PAIN) THAT COINCIDED WITH SEEING THE ERI MESSAGE. THE PATIENT HAD INCREASED THE AMPLITUDE AND WAS STILL NOT GETTING ANY STIMULATION SENSATION OR THERAPEUTIC EFFECT. THEY ALSO REPORTED THAT THEY HAVE DISCUSSED GETTING A SURESCAN DEVICE WITH THEIR PHYSICIAN SO THEY MAY HAVE AN MRI. LAST YEAR THEY HAD AN OCCIPITAL STROKE (THEY WERE BORN WITH VERY SMALL CEREBRAL ARTERIES; SO IDIOPATHIC IN NATURE) AND SHE WAS NOT ABLE TO HAVE AN MRI AT THAT TIME. THE PATIENT CONFIRMED THIS ISSUE WAS NOT RELATED TO THEIR STIMULATOR. RELEVANT MEDICAL HISTORY INCLUDES COMPLEX REGIONAL PAIN SYNDROME. ADDITIONAL INFORMATION HAS BEEN REQUESTED, BUT WAS NOT AVAILABLE AS OF THE DATE OF THIS REPORT. IF RECEIVED, A FOLLOW-UP REPORT WILL BE SENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    524872 PRIMEADVANCED STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF LGW MEDTRONIC MED REL MEDTRONIC PUERTO RICO 37702

    Patients

    Seq Age Sex Outcome Treatment
    1 00044 YR "SEE H10...."| SEE H10