BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ACTIVA

    MDR report key: 4699054 · Received April 16, 2015

    Report

    Report Number
    3004209178-2015-07362
    Event Type
    Injury
    Date Received
    April 16, 2015
    Report Date
    March 25, 2015
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO.
    Product Code
    MRU
    PMA / PMN Number
    H020007
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    ANALYSIS OF THE LEAD (LOT NO. V712879) FOUND THE CONDUCTOR ON THE PROXIMAL END OF THE LEAD WAS BROKEN AND THE OUTER INSULATION OF THE LEAD BODY HAD BREACHED ESC. THE #0 CONDUCTOR WAS BROKEN AT THE CONNECTOR WELD SITE. THERE WAS BREACHED ESC ON THE OUTER INSULATION AT 8.2 CM FROM THE DISTAL END OF THE DISTAL SEGMENT OF THE LEAD.

    Additional Manufacturer Narrative · 1

    CONCOMITANT MEDICAL PRODUCTS: PRODUCT ID: 37603, SERIAL# (B)(4), IMPLANTED: (B)(6) 2014, PRODUCT TYPE: IMPLANTABLE NEUROSTIMULATOR. PRODUCT ID: 3387S-40, LOT# V712879, IMPLANTED: (B)(6) 2011, PRODUCT TYPE: LEAD. PRODUCT ID: 37642, SERIAL# (B)(4), PRODUCT TYPE: PROGRAMMER, PATIENT. PRODUCT ID: 7482A40, SERIAL# (B)(4), IMPLANTED: (B)(6) 2011, PRODUCT TYPE: EXTENSION. PRODUCT ID: 3387S-40, LOT# VA0J7PK, IMPLANTED: (B)(6) 2014, PRODUCT TYPE: LEAD. PRODUCT ID: 3708660, SERIAL# (B)(4), IMPLANTED: (B)(6) 2014, PRODUCT TYPE: EXTENSION. (B)(4).

    Additional Manufacturer Narrative · 1

    CONCOMITANT MEDICAL PRODUCTS: PRODUCT ID 37603, SERIAL# (B)(4), IMPLANTED: (B)(6) 2015, PRODUCT TYPE: IMPLANTABLE NEUROSTIMULATOR. PRODUCT ID 3708660, SERIAL# (B)(4), PRODUCT TYPE: EXTENSION. (B)(4). 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.

    Additional Manufacturer Narrative · 1

    CONCLUSION CODE WAS UPDATED. FDC IS APPLICABLE FOR THE LEAD (LOT # V712879) IT IS NOTED FDC IS STILL APPLICABLE TO THE INS (S/N (B)(4)).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THERE WAS A NEW OPEN CIRCUIT ON THE LEFT SIDE. THE PATIENT HAD BEEN IN AND OUT OF THE OFFICE WITH PROBLEMS FOR THE PAST MONTH PRIOR TO THE DATE OF THIS REPORT AND HAD BEEN EXPERIENCING A LOSS OF EFFECT. IMPEDANCES FROM A FEW MONTHS PRIOR TO THE DATE OF THIS REPORT WERE AVAILABLE. WHEN IMPEDANCES WERE RUN AT 0.7V ALL VALUES HAD SHOWN GREATER THAN 10,000 AT MULTIPLE DIFFERENT CONTACTS. THEY HAD BROUGHT IT UP TO 3V AND IT WAS SHOWING VALUES 14,000 AND 15,000 AND THEY FELT THE ISSUE WAS CENTERED AROUND 0. EVERYTHING WAS NORMAL AND SOMETHING HAD DRASTICALLY CHANGED. AN IMPEDANCE CHECK FROM A MONTH PRIOR TO THE DATE OF THIS REPORT HAD SHOWN ALL NORMAL. THERAPY IMPEDANCE WAS AT 4.21MA AND 990 OHMS. THE HEALTHCARE PROFESSIONAL WAS JUST PRESUMING THE PATIENT WAS HAVING INTERMITTENT LOSS ON THE LEFT SIDE. LEFT SIDE IMPEDANCE WAS RUN AT C-1+, 4.2V, 210 PW AND 250 RATE. AT 1.5V ELECTRODE IMPEDANCE VALUES WERE C/0-14089, C/1-930, C/2-1321, C/3-785, 0/1-1489, 0/2-15196, 0/3-14903, 0/4-18333, 0/5-1504 AND 0/6-1677. THE PATIENT WAS GOING TO HAVE AN MRI OF THE BRAIN THAT WAS RELATED TO THE DEVICE THERAPY ISSUES. THE PATIENT WAS BEING PUT UNDER ANESTHESIA SO HE COULD TOLERATE HAVING THE MRI SCAN. THE PATIENT WAS HAVING ISSUES WITH BOTH THE RIGHT AND LEFT SIDE DEEP BRAIN STIMULATOR SYSTEMS. THE PATIENT HAD SYSTEMS CHANGED OUT A COUPLE OF TIMES DUE TO THE PATIENT GROWING. DYSTONIA SYMPTOMS HAVE COME BACK AND THE DEEP BRAIN STIMULATOR SYSTEMS WERE NOT HELPING THE PATIENT. IT WAS UNKNOWN WHEN SYMPTOM BENEFIT HAD CHANGED FOR THE PATIENT. AT THE LAST IMPLANTABLE NEUROSTIMULATOR (INS) CHANGE OUT THE PATIENT HAD BENEFIT FOR ABOUT 2 WEEKS AND THEN NEEDED HIGHER SETTINGS TO GET BENEFIT. NO INTERVENTION OR OUTCOME WAS PROVIDED. FURTHER FOLLOW-UP IS BEING CONDUCTED TO OBTAIN THIS INFORMATION. IF ADDITIONAL INFORMATION IS RECEIVED A SUPPLEMENTAL REPORT WILL BE SUBMITTED.

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION RECEIVED REPORTED THE PATIENT HAD A GRADUAL LOSS OF THERAPEUTIC EFFECT AND A GRADUAL LOSS OF STIMULATION. THE PATIENT PREVIOUSLY HAD A 50 PERCENT OR GREATER SYMPTOMS REDUCTION. THE CAUSE OF THE EVENT WAS NOT DETERMINED AND REPROGRAMMING WAS NEEDED. THE PATIENT WAS ADMITTED TO THE HOSPITAL ON (B)(6) 2015. AN MRI WAS DONE UNDER GENERAL ANESTHETIC. THE PATIENT HAD NOT RECOVERED AND THE SYMPTOMS/ISSUE WAS ONGOING. DURING A REVISION, AN IMPEDANCE MEASUREMENT SHOWED THAT ALL COMBINATIONS WITH ELECTRODE ZERO WERE HIGH AND OUT OF RANGE. THE LEAD WAS CHECKED WITH AN EXTERNAL NEUROSTIMULATOR AND ALL IMPEDANCES WERE GOOD. THE PATIENT'S HEALTHCARE PROFESSIONAL (HCP) DECIDED TO REPLACE THE EXTENSION AND THE IMPLANTABLE NEUROSTIMULATOR (INS), BUT THE PROBLEM WAS STILL OCCURRING. THE LEAD WAS THEN REMOVED DUE A RETURN OF SYMPTOMS, OUT OF RANGE IMPEDANCES ON ELECTRODE ZERO, AND BEING UNABLE TO REPROGRAM AROUND ELECTRODE ZERO WITH GOOD BENEFIT. AFTER THE LEAD WAS REPLACED, ALL IMPEDANCES WERE WITHIN RANGE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    253082 ACTIVA STIMULATOR, ELECTRICAL, IMPLANTED, FOR PARKINSONIAN TREMOR MRU MEDTRONIC PUERTO RICO OPERATIONS CO. 37602

    Patients

    Seq Age Sex Outcome Treatment
    1 00017 YR Hospitalization| R