BEUDAMED
    FDA Adverse Event Injury Summary report: N

    RESTORE SENSOR

    MDR report key: 3952652 · Received July 23, 2014

    Report

    Report Number
    3004209178-2014-13410
    Event Type
    Injury
    Date Received
    July 23, 2014
    Report Date
    June 30, 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
    MI, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    CONCOMITANT MEDICAL PRODUCTS: PRODUCT ID: 3888-45, LOT# VA06UQD, IMPLANTED: (B)(6) 2013, EXPLANTED: (B)(6) 2014, PRODUCT TYPE: LEAD. PRODUCT ID: 3487A-56, LOT# VA09BJS, IMPLANTED: (B)(6) 2013, EXPLANTED: (B)(6) 2014, PRODUCT TYPE: LEAD. PRODUCT ID: 3888-33, LOT# VA07EYB, IMPLANTED: (B)(6) 2013, EXPLANTED: (B)(6) 2014, PRODUCT TYPE: LEAD. PRODUCT ID: 37754, SERIAL# (B)(4), PRODUCT TYPE: RECHARGER. PRODUCT ID: 37746, SERIAL# (B)(4), , PRODUCT TYPE: PROGRAMMER, PATIENT. PRODUCT ID: 3487A-56, LOT# VA05B7E, IMPLANTED: (B)(6) 2013, EXPLANTED: (B)(6) 2014, PRODUCT TYPE: LEAD. PRODUCT ID: 3708220, SERIAL# (B)(4), IMPLANTED: (B)(6) 2013, PRODUCT TYPE: EXTENSION. (B)(4).

    Additional Manufacturer Narrative · 1

    (B)(4).

    Additional Manufacturer Narrative · 1

    (B)(4).

    Additional Manufacturer Narrative · 1

    ANALYSIS OF THE LEAD, LOT # VA06UQD, FOUND NO SIGNIFICANT ANOMALY. THE LEAD BODY HAD BE CUT THROUGH AND SEGMENTED. ANALYSIS OF THE LEAD, LOT # VA09BJS, FOUND NO SIGNIFICANT ANOMALY. THE LEAD BODY HAD BE CUT THROUGH AND SEGMENTED. ANALYSIS OF THE LEAD, LOT # VA07EYB, FOUND NO SIGNIFICANT ANOMALY. THE LEAD BODY CONDUCTOR HAD BROKEN DUE TO OVERSTRESS OR DAMAGE. ANALYSIS OF THE LEAD, LOT # VA05B7E, FOUND NO SIGNIFICANT ANOMALY. THE LEAD BODY HAD BE CUT THROUGH AND SEGMENTED.

    Additional Manufacturer Narrative · 1

    ANALYSIS RESULTS WERE NOT AVAILABLE AS OF THE DATE OF THIS REPORT. A FOLLOW-UP REPORT WILL BE SUBMITTED WHEN ANALYSIS IS COMPLETE.

    Additional Manufacturer Narrative · 1

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

    Description of Event or Problem · 1

    IT WAS REPORTED THE PATIENT¿S TWO EPIDURAL PERCUTANEOUS LEADS WERE REPLACED WITH A PADDLE LEAD BECAUSE THE PATIENT HAD LESS THAN DESIRABLE PAIN RELIEF, LESS THAN 50% THERAPY RELIEF. IT WAS REPORTED THE PERIPHERAL NERVOUS SYSTEM (PNS) LEADS WERE REMOVED DUE TO A BURNING SENSATIONS ASSOCIATED WITH THE PNS LEADS. ADDITIONAL INFORMATION RECEIVED REPORTED THERE WAS A 50% OR GREATER SYMPTOM REDUCTION. IT WAS NOTED THAT THE CAUSE OF THE BURNING SENSATION AND LACK OF THERAPEUTIC EFFECT WERE UNKNOWN BUT AN IMPEDANCE TEST SHOWED NORMAL LIMITS. IT WAS UNKNOWN IF REPROGRAMMING WAS ATTEMPTED PRIOR TO REVISION. IT WAS NOTED THE MANUFACTURER REPRESENTATIVE WAS SCHEDULED TO SEE THE PATIENT AT THEIR POST-OPERATION APPOINTMENT BUT IT HAD NOT BEEN SCHEDULED AT THE TIME OF REPORT. LASTLY, IT WAS NOTED AFTER THE SURGERY THE PATIENT HAD APPROPRIATE AND DESIRED STIMULATION PATTERNS.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT¿S LEADS AND EXTENSIONS WERE EXPLANTED. THE EXPLANT WAS NOTED TO HAVE BEEN ELECTIVE. THE PATIENT RECOVERED WITHOUT SEQUELAE.

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION RECEIVED REPORTED A FAILURE OF THE SPINAL CORD STIMULATOR. THE PATIENT¿S COVERAGE HAD NOT PROVIDED HIM WITH ADEQUATE PAIN RELIEF. MULTIPLE REPROGRAMMING CONFIGURATIONS HAD BEEN TRIED WITH NO IMPROVEMENT. ONLY ONE ELECTRODE WAS OPERATING PROPERLY WHICH WAS PROVIDING HIM WITH RELIEF IN HIS RIGHT LOW BACK. IF THE LEFT LOW BACK LEAD WAS TURNED ON, IT WOULD CAUSE A BURNING SENSATION IN THE SURFACE OF THE SKIN OVERLYING THE LEAD. IN REGARDS TO THE TWO THORACIC LEADS, ONE LEAD WAS BROKEN AND NON-FUNCTIONAL AND THE OTHER ONE CAUSED EXTREME DISCOMFORT DOWN THE ANTERIOR ASPECT OF HIS RIGHT LEG WHEN IT WAS TURNED ON. NO FURTHER FOLLOW-UP WAS REQUIRED AS THIS WAS ONLY FURTHER INFORMATION PERTAINING TO THE SAME EXPLANT THAT WAS ALREADY FOLLOWED UP ON. ALL KNOW INFORMATION HAS BEEN REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    431424 RESTORE SENSOR STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF LGW MEDTRONIC MED REL MEDTRONIC PUERTO RICO 37714

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention