BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ACTIVA

    MDR report key: 4456900 · Received January 27, 2015

    Report

    Report Number
    3004209178-2015-01280
    Event Type
    Injury
    Date Received
    January 27, 2015
    Report Date
    January 8, 2015
    Manufacturer
    MEDTRONIC MED REL MEDTRONIC PUERTO RICO
    Product Code
    MRU
    PMA / PMN Number
    H020007
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AZ, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    CONCOMITANT MEDICAL PRODUCTS: PRODUCT ID 37642, SERIAL# (B)(4), PRODUCT TYPE: PROGRAMMER, PATIENT. PRODUCT ID 37651, SERIAL# (B)(4), PRODUCT TYPE: RECHARGER. PRODUCT ID 7482A66, SERIAL# (B)(4), IMPLANTED: (B)(6) 2008, PRODUCT TYPE: EXTENSION. PRODUCT ID 7482A66, SERIAL# (B)(4), IMPLANTED: (B)(6) 2008, PRODUCT TYPE: EXTENSION. PRODUCT ID 3387S-40, LOT# V101646, IMPLANTED: (B)(6) 2008, PRODUCT TYPE: LEAD. PRODUCT ID 3387S-40, LOT# V101646, IMPLANTED: (B)(6) 2008, PRODUCT TYPE: LEAD. PRODUCT ID 7482A66, SERIAL# (B)(4), IMPLANTED: (B)(6) 2008, PRODUCT TYPE: EXTENSION. PRODUCT ID 7482A66, SERIAL# (B)(4), IMPLANTED: (B)(6) 2008, PRODUCT TYPE: EXTENSION. (B)(4).

    Additional Manufacturer Narrative · 1

    CONCOMITANT MEDICAL PRODUCTS: PRODUCT ID 37642, SERIAL# (B)(4), PRODUCT TYPE: PROGRAMMER, PATIENT; PRODUCT ID 37651, SERIAL# (B)(4), PRODUCT TYPE: RECHARGER; PRODUCT ID 7482A66, SERIAL# (B)(4), IMPLANTED: (B)(6) 2008, PRODUCT TYPE: EXTENSION; PRODUCT ID 7482A66, SERIAL# (B)(4), IMPLANTED: (B)(6) 2008, PRODUCT TYPE: EXTENSION; PRODUCT ID 3387S-40, LOT# V101646, IMPLANTED: (B)(6) 2008, PRODUCT TYPE: LEAD; PRODUCT ID 3387S-40, LOT# V101646, IMPLANTED: (B)(6) 2008, PRODUCT TYPE: LEAD. (B)(4).

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION RECEIVED REPORTED THE IMPEDANCE ISSUE HAD OCCURRED YEARS AFTER SURGERY. IMPEDANCES HAD RESOLVED AFTER THE EX TENSION WIRE WAS SURGICALLY REPLACED THE IMPEDANCE HAD GONE TO NORMAL. THE CAUSE WAS DETERMINED TO BE THE EXTENSION AND WAS DEVICE RELATED. THERE WERE NO LEAD FRACTURES. THERE WAS NOT A 50% OR GREATER SYMPTOM REDUCTION, THERE WAS A 30-40% SYMPTOM REDUCTION. THE PATIENT HAD NOT RECOVERED, SYMPTOMS/ISSUE WAS ONGOING.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT COUPLE OF DAYS PRIOR TO THE REPORT, THE PATIENT EXPERIENCED SHOCKING SENSATION ON THE BACK OF THEIR HEAD AND ALSO HAD BEEN EXPERIENCING MUSCLE SPASM ON THE RIGHT SIDE SINCE EXPERIENCING THE SHOCKING. IT WAS STATED THAT THE PATIENT HAD TROUBLE WRITING AND HAD SPASMS WHEN THEY WALKED. RETURN OF THE PATIENT SYMPTOMS WAS WORSE WHEN THEY WALKED. THE REPORTER NOTED THAT THE PATIENT WAS PROGRAMMED WITH CASE AND 4 ON THE RIGHT SIDE AND THE THERAPY IMPEDANCE ON THE RIGHT WAS 3774 OHMS WITH 0.940MA. THE DAY PRIOR TO THE REPORT, THE THERAPY IMPEDANCE WAS MEASURED AT 2.190MA AND 0.996 WITH C/4: 3629 OHMS, 4/5: 4087 OHMS, 4/6: 4548 OHMS AND 4/7 4637 OHMS. IT WAS NOTED THAT IN MAY OF 2014 THE THERAPY IMPEDANCE WAS 1260 OHMS AND 2.02 MA. THERE HAD BEEN NO FALLS OR TRAUMA. IT WAS REPORTED X-RAYS OF THE PATIENT HEAD, CHEST AND ABDOMEN HAD BEEN DONE WITH NO OBVIOUS BREAK SEEN. THE X-RAYS WERE NOT DETAILED ENOUGH TO SEE THE COILS. THE PATIENT LEFT IMPEDANCE AND THERAPY IMPEDANCE WERE ALL NORMAL. THE MANUFACTURER REPRESENTATIVE STATED THAT IMPEDANCES WERE TESTED TOWARDS THE END OF THE PATIENT¿S APPOINTMENT AND THE IMPEDANCES VALUES WERE EVEN HIGHER ON CONTACT 4 AND THE THERAPY IMPEDANCE READ HIGH. 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.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    61406 ACTIVA STIMULATOR, ELECTRICAL, IMPLANTED, FOR PARKINSONIAN TREMOR MRU MEDTRONIC MED REL MEDTRONIC PUERTO RICO 37612

    Patients

    Seq Age Sex Outcome Treatment
    1 00023 YR Required Intervention