BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ACTIVA

    MDR report key: 4181863 · Received October 17, 2014

    Report

    Report Number
    3004209178-2014-19923
    Event Type
    Injury
    Date Received
    October 17, 2014
    Report Date
    September 29, 2014
    Manufacturer
    MEDTRONIC MED REL MEDTRONIC PUERTO RICO
    Product Code
    MHY
    PMA / PMN Number
    P960009
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    CONCOMITANT MEDICAL PRODUCTS: PRODUCT ID: 37602, SERIAL# (B)(4), IMPLANTED: (B)(6) 2013, PRODUCT TYPE: IMPLANTABLE NEUROSTIMULATOR. PRODUCT ID: 3387-40, LOT# J0519429V, IMPLANTED: (B)(6) 2005, PRODUCT TYPE: LEAD. PRODUCT ID: 748251, SERIAL# (B)(4), IMPLANTED: (B)(6) 2005, PRODUCT TYPE: EXTENSION. PRODUCT ID: 3387-40, LOT# J0454516V, IMPLANTED: (B)(6) 2004, PRODUCT TYPE: LEAD. PRODUCT ID: 37642, SERIAL# (B)(4), PRODUCT TYPE: PROGRAMMER, PATIENT. PRODUCT ID: 748251, SERIAL# (B)(4), IMPLANTED: (B)(6) 2004, EXPLANTED: (B)(6) 2014, PRODUCT TYPE: EXTENSION. RESULT: WAS ALSO APPLICABLE. ANALYSIS OF THE IMPLANTABLE NEUROSTIMULATOR (INS) FOUND INSIGNIFICANT ANOMALIES, THE INS WAS FUNCTIONALLY OK. ANALYSIS OF THE EXTENSION FOUND THE #1 CONDUCTOR WAS BROKEN NEAR THE #1 DISTAL CONNECTOR, 1.2CM FROM THE DISTAL END AND THE #1 CONDUCTOR WAS BROKEN 2.5CM FROM THE DISTAL END. THERE WAS CORROSION IN THE #1 CONDUCTOR LUMEN IN THE DISTAL END OF THE EXTENSION. THE #1 TRANSITION CRIMP WAS NOT OBSERVED AND THE #1 CONNECTOR WAS CORRODED.

    Additional Manufacturer Narrative · 1

    CONCOMITANT PRODUCTS: PRODUCT ID: 37602, SERIAL# (B)(4), IMPLANTED: (B)(6) 2013, PRODUCT TYPE: IMPLANTABLE NEUROSTIMULATOR. PRODUCT ID: 3387-40, LOT# J0519429V, IMPLANTED: (B)(6) 2005, PRODUCT TYPE: LEAD. PRODUCT ID: 748251, SERIAL# (B)(4), IMPLANTED: (B)(6) 2005, PRODUCT TYPE: EXTENSION. PRODUCT ID: 3387-40, LOT# J0454516V, IMPLANTED: (B)(6) 2004, PRODUCT TYPE: LEAD. PRODUCT ID: 37642, SERIAL# (B)(4), PRODUCT TYPE: PROGRAMMER, PATIENT. (B)(4). PLEASE SEE MANUFACTURER REPORT # 3004209178-2014-19922 FOR INFORMATION ON THE PATIENT'S CONCOMITANT SYSTEM.

    Description of Event or Problem · 1

    IT WAS REPORTED THERE WAS HIGH IMPEDANCE THAT READ >40,000 OHMS. THEY WERE NOTIFIED THE DAY PRIOR TO REPORT OF THE HIGH IMPEDANCE ISSUE. THE OPEN CIRCUIT WAS SEEN ON ALL CONTACT PAIRS WITH ELECTRODE 1. THE DOCTOR DID REPROGRAMMING AROUND CONTACT 1 AND THE PATIENT WAS NOW PROGRAMMED ON 3+ 2- 0-. EVEN WITH REPROGRAMMING TO 3+ 2- 0-, THE PATIENT CONTINUED TO REPORT SHOCKING SENSATION AT HIS RIGHT SIDE OF BODY, LOWER AND UPPER EXTREMITIES BUT THE SHOCKING WAS MILD AND NOT AS STRONG AS BEFORE. THE NEW PROGRAM CONTROLLED HIS TREMOR. THE PATIENT WENT TO BED 4 DAYS PRIOR TO REPORT AND FELT FINE BUT DURING THE MIDDLE OF THE NIGHT THEY HAD INTERMITTENT SHOCKING SENSATIONS UNTIL THEY TURNED HIS STIMULATION OFF. IT WAS A SUDDEN CHANGE BUT THEY DENIED ANY FALLS OR TRAUMA. THERE WAS NOTHING NEW IN HIS BEDROOM BESIDES THEY SLEPT ON AN EXTRA PILLOW. WHEN PRESSURE WAS APPLIED TO THE LEAD/EXTENSION SITE WHILE THE PATIENT TURNED HIS HEAD TO THE RIGHT THERE WAS NO SHOCKING SENSATION. ELECTRODE IMPEDANCE TESTING WAS DONE AT 3V WITH PRESSURE APPLIED AND HEAD TURNED TO THE RIGHT SIDE: C0: 1357 OHMS, C1: >40K OHMS, C2: 726 OHMS, C3: 899 OHMS, 01: >40K OHMS, 02: 1635 OHMS, 03: 1875 OHMS, 12: >40K OHMS, 13: >40K OHMS, 23: 1153 OHMS. PRESSURE WAS APPLIED TO THE EXTENSION/IMPLANTABLE NEUROSTIMULATOR (INS) SITE WHILE THEIR HEAD WAS TURNED TO THE RIGHT SIDE, ELECTRODE IMPEDANCE WAS TESTED AT 3V: C0: 1374 OHMS, C1: >40K OHMS, C2: 723 OHMS, C3: 914 OHMS, 01: >40K OHMS, 02: 1636 OHMS, 03: 1904 OHMS, 12: >40K OHMS, 13: >40K OHMS, 23: 1155 OHMS. WHEN THE STIMULATION WAS OFF THERE WAS NO SHOCKING SENSATION. NO INTERVENTIONS OR OUTCOME WERE REPORTED REGARDING THIS EVENT. FURTHER FOLLOW-UP IS BEING CONDUCTED TO OBTAIN THIS INFORMATION. IF ADDITIONAL INFORMATION IS RECEIVED, A FOLLOW-UP REPORT WILL BE SENT.

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION RECEIVED REPORTED THERE WAS HIGH IMPEDANCE OF >40 ,000 OHMS ON CONTACT 0. THE ISSUE WAS RESOLVED BUT THE CAUSE OF THE ISSUE WAS NOT DETERMINED. AN EXPLANT OF THE EXTENSION AND INS WAS REQUIRED AS A RESULT OF THE EVENT AND IMPEDANCE TESTING WAS PERFORMED FOR TROUBLESHOOTING PURPOSES. THE EXTENSION AND INS WERE REPLACED AND IMPEDANCES WERE WITHIN NORMAL RANGE AFTERWARDS. THE PATIENT STATUS AT THE TIME OF REPORT WAS ALIVE WITH NO INJURY. THE PATIENT EXPERIENCED ELECTRICAL SHOCKING SENSATION BUT IT RESOLVED WITH THE REPLACEMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    661051 ACTIVA STIMULATOR, ELECTRICAL, IMPLANTED, FOR PARKINSONIAN TREMOR MHY MEDTRONIC MED REL MEDTRONIC PUERTO RICO 37602

    Patients

    Seq Age Sex Outcome Treatment
    1 00054 YR Required Intervention