BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ACTIVA

    MDR report key: 4616942 · Received March 19, 2015

    Report

    Report Number
    3004209178-2015-05034
    Event Type
    Injury
    Date Received
    March 19, 2015
    Report Date
    February 25, 2015
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO.
    Product Code
    MHY
    PMA / PMN Number
    P960009
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    CONCOMITANT MEDICAL PRODUCTS: PRODUCT ID: 37602, SERIAL# (B)(4), IMPLANTED: (B)(6) 2014, PRODUCT TYPE: IMPLANTABLE NEUROSTIMULATOR. PRODUCT ID: 3389-40, LOT# J0428351V, IMPLANTED: (B)(6) 2004, PRODUCT TYPE: LEAD. PRODUCT ID: 37642, SERIAL# (B)(4), PRODUCT TYPE: PROGRAMMER, PATIENT. PRODUCT ID: 748240, SERIAL# (B)(4), IMPLANTED: (B)(6) 2004, PRODUCT TYPE: EXTENSION. PRODUCT ID: 3389S-40, LOT# V452133, IMPLANTED: (B)(6) 2010, PRODUCT TYPE: LEAD. PRODUCT ID: 7482A40, SERIAL# (B)(4), IMPLANTED: (B)(6) 2010, PRODUCT TYPE: EXTENSION. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE HEALTHCARE PROFESSIONAL HAD NOTICED SOME IMPEDANCES THAT WERE OUT OF THE ORDINARY. THE PATIENT HAD HAD A BATTERY REPLACEMENT IN (B)(6) PRIOR TO THE DATE OF THIS REPORT AND HAD NOT HAD ANY THERAPY PROBLEMS PRIOR TO THE REPLACEMENT. THE PATIENT HAD BEEN FINE FOR ABOUT 2 WEEKS FOLLOWING THE SURGERY BUT THEN HAD NOTICED A RETURN OF SYMPTOMS AND SYMPTOMS RETURN HAD PRIMARILY BEEN ON THE RIGHT SIDE OF THE BODY. THE PATIENT HAD ALSO NOTICED A NEW SYMPTOM OF GENERALLY BECOMING FROZEN THROUGH THEIR ENTIRE BODY. THE PATIENT HAD EXPERIENCED MANY FALLS BUT THERE WERE NO SPECIFICS AS TO IF THEY HAD OCCURRED IN THE TIME PRECEDING THE SYMPTOM RETURN. THE PATIENT HAD NOT FELT ANY ABNORMAL STIMULATION OR ANYTHING UNUSUAL WITH THE SYSTEM. THE LEFT SUBTHALAMIC NUCLEUS (STN) AT 3.0V HAD IMPEDANCE READINGS OF : C/0-4478, C/1-2537, C/2-770, C/3-1921, 0/1-2509, 0/2-3799, 0/3-4646, 1/2-1688,1/3-2509 AND 2/3-1429 OHMS. THE RIGHT STN AT 3.0V HAD IMPEDANCE READINGS OF: C/0-1093, C/1-14899, C/2-15414, C/3-996, 0/1-14156, 0/2-14550, 0/3-35, 1/2-13025, 1/3-14025 AND 2/3-14415 OHMS. THERAPY SETTINGS ON THE LEFT WITH INTERLEAVING WERE PROGRAM 1 C+2-, 0.8V, 100US AND 125HZ AND PROGRAM 2 C+1-, 2.3V, 110US AND 125HZ. RIGHT SIDE WAS C+0-, 2.1V, 60US AND 125HZ. THE HEALTHCARE PROFESSIONAL HAD ORDERED THE PATIENT TO GET X-RAYS TO SEE IF THERE WAS A FRACTURE IN THE SYSTEM. THE PATIENT NEEDED A MRI ON (B)(6) 2015 FOR A REVISION SURGERY ON THE FOLLOWING DAY. IT WAS NOTED THAT SOMETIME IN THE PAST 6 WEEKS PRIOR TO (B)(6) 2015 THE PATIENT¿S LEADS HAD BOTH SNAPPED BEHIND EACH EAR. AN X-RAY WAS TAKEN AND IT HAD SHOWED THE LEADS WERE COMPROMISED. THERE WAS A LOSS OF THERAPEUTIC EFFECT. THE PATIENT HAD SEEN AN INFORMATION SCREEN ON THE PATIENT PROGRAMMER TO REPLACE THE BATTERIES, THERE WAS A PROBLEM WITH THE PATIENT PROGRAMMER. THE CAUSE OF THE LEAD BREAK WAS THE SEVERAL FALLS THAT THE PATIENT HAD REPORTED. IMPEDANCE READINGS ON (B)(6) 2015 FOR THE LEFT SIDE WERE C/0-4557, C/1-2619, C/2-814, C/3-1995, 0/1-2545, 0/2-3900, 0/3-4768, 1/2-1738, 1/3-2582 AND 2/3-1480. ON THE RIGHT SIDE THEY WERE C/0-808, C/1-9040, C/2-660, C/3-3029, 0/1-8472, 0/2-110, 0/3-2080, 1/2-8291, 1/3-12169 AND 2/3-1375. BOTH LEADS WERE EXPLANTED ON (B)(6) 2015, ONLY THE LEADS WERE EXPLANTED. THE RIGHT LEAD HAD SHOWN A FRACTURE BELOW THE EAR AND THE LEFT LEAD WAS PULLED DOWN RESULTING IN CONNECTOR IN THE NECK AREA. THE PATIENT PROGRAMMER WAS REVIEWED WITH THE PATIENT AND FAMILY. THERA PY WAS TURNED BACK ON POST IMPLANT ON (B)(6) 2015 AND ALL IMPEDANCES WERE IN NORMAL RANGE. REFERENCE MANUFACTURER¿S REPORT NUMBER: 3004209178-2015-05032.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    188666 ACTIVA STIMULATOR, ELECTRICAL, IMPLANTED, FOR PARKINSONIAN TREMOR MHY MEDTRONIC PUERTO RICO OPERATIONS CO. 37602

    Patients

    Seq Age Sex Outcome Treatment
    1 00072 YR Required Intervention