BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ACTIVA

    MDR report key: 7210783 · Received January 22, 2018

    Report

    Report Number
    3004209178-2018-01144
    Event Type
    Injury
    Date Received
    January 22, 2018
    Date of Event
    January 1, 2015
    Report Date
    April 27, 2018
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO.
    Product Code
    MHY
    UDI-DI
    00643169529786
    PMA / PMN Number
    P960009
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    REFERENCES THE MAIN COMPONENT AND OTHER APPLICABLE COMPONENTS ARE: PRODUCT ID: 37601, SERIAL# (B)(4), IMPLANTED: (B)(6) 2013, EXPLANTED: (B)(6) 2016, PRODUCT TYPE: IMPLANTABLE NEUROSTIMULATOR. PRODUCT ID: 37601, SERIAL# (B)(4), IMPLANTED: (B)(6) 201 7, EXPLANTED: (B)(6) 2017, PRODUCT TYPE: IMPLANTABLE NEUROSTIMULATOR. PRODUCT ID: 7482A51, SERIAL# (B)(4), IMPLANTED: (B)(6) 2009, PRODUCT TYPE: EXTENSION. PRODUCT ID: 7482A51, SERIAL# (B)(4), IMPLANTED: (B)(6) 2009, PRODUCT TYPE: EXTENSION. DATE OF EVENT IS AN APPROXIMATE. A GOOD FAITH EFFORT WILL BE MADE TO OBTAIN THE APPLICABLE INFORMATION RELEVANT TO THE REPORT. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Additional Manufacturer Narrative · 1

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

    Additional Manufacturer Narrative · 1

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

    Description of Event or Problem · 1

    INFORMATION WAS RECEIVED FROM A HEALTHCARE PROVIDER REGARDING A PATIENT WHO WAS IMPLANTED WITH A NEUROSTIMULATOR FOR PARKINSON'S DUAL. IT WAS REPORTED THAT THERE WAS AN ERROR CODE ON THE CLINICIAN PROGRAMMER THAT SAID: DELIVERED AMPLITUDE MAYBE LOWER THAN THE SELECTED AMPLITUDE FOR 1 OR MORE PROGRAMS, CHECK THE ELECTRODE IMPEDANCE, CHECK THE PROGRAMS, REDUCE THE NUMBER OF ACTIVE ELECTRODES, CHECK PROGRAMS AND DECREASE AMPLITUDE. CALLER SAID THAT THE PATIENT WAS IN THE OFFICE FOR PROGRAMMING. PATIENT THERAPY IS REPORTED TO BE DOING FINE AND THE PATIENT IS DOING WELL. CALLER FURTHER REPORTS THAT THE DEVICE WAS REPLACED IN (B)(6) 2017 DUE TO END OF SERVICE (EOS) AND WAS SOONER THAN EXPECTED. CALLER REPORTS THAT THEY SAW THE PATIENT IN (B)(6) 2017 AND BY (B)(6) 2017 IT NEEDED TO BE REPLACED. THERE WAS MORE OF A HIGH IMPEDANCE READING ON THE DEVICE THAT WAS REPLACED IN (B)(6) 2017. THE SAME ERROR MESSAGE WAS SEEN ON THE DEVICE THAT WAS REPLACED. ELECTRODE IMPEDANCE TESTED LEFT SIDE 0.7V: C0: 1056 OHMS C1: 884 OHMS C2: 795 OHMS C3: 869 OHMS 01: 1048 OHMS 02: 1283 OHMS 03: 1504 OHMS 12: 908 OHMS 13: 1245 OHMS 23: 901 OHMS RIGHT SIDE 0.7V: C4: 1909 OHMS C5: 3143 OHMS C6: 5711 OHMS C7: 8923 OHMS 45: 1329 OHMS 46: 3887 OHMS 47: 7271 OHMS 56: 2725 OHMS 57: 6237 OHMS 67: 4014 OHMS RIGHT SIDE 3.0V: C4: 1606 OHMS C5: 2184 OHMS C6: 5310 OHMS C7: 8224 OHMS 45: 1226 OHMS 46: 3702 OHMS 47: 6918 OHMS 56: 2537 OHMS 57: 5858 OHMS 67: 3779 OHMS PATIENT IS PROGRAMMED LEFT STN1: C+2- 3.0V/60PW/120HZ. THERAPY IMPEDANCE: 771 OHMS AND 3.863MA LEFT STN2: C+3- 1.8V/60PW/120HZ. THERAPY IMPEDANCE: 835 OHMS AND 2.153 MA RIGHT STN: C+4-5- 3.0V/60PW/120HZ. THERAPY IMPEDANCE: 1650 OHMS AND 1.832MA INS VOLTAGE 2.9V. THE CALLER FURTHER REPORTS THAT THE LEFT SIDE EXTENSION IS PROTRUDING MORE THAN USUAL AND REPORTS SHE CAN PALPATE THAT SIDE. CALLER REPORTS SHE THE IMPLANT IS ON THE LEFT SIDE CHEST. CALLER REPORTS WHEN THE PATIENT MOVES THERE ARE NO ABNORMAL SYMPTOMS OR THERAPY SEEN. ELECTRODE IMPEDANCE TESTED WITH HEAD TURNED TO THE RIGHT SIDE AND LEFT ARM MOVED UP, REPORTS THE RIGHT STN IMPEDANCE REMAINS HIGH, NO CHANGE IN VALUES. IN (B)(6) 2017 THERE WAS A REPORT THAT THE RIGHT SIDE ALSO HAD HIGH IMPEDANCE. THERAPY IMPEDANCE ON THE RIGHT SIDE: 664 OHMS AND 4.391MA. INS VOLTAGE WAS 2.84V. IN (B)(6) 2017 THERE WAS UNKNOWN IMPEDANCE READINGS BUT VOLTAGE WAS EOS AND LESS THAN 2.6V. ON (B)(6) THERE WERE HIGH IMPEDANCE READINGS; 4-6K OHMS. CALLER REPORTS WHEN THEY TAP ON THE CHEST WITH THE IMPLANT, THERE IS NO THERAPY CHANGE, 2.9V. CALLER REPORTS THE PATIENT HIT THERE HEAD ON THERE CAR BACK IN 2015 WHERE THE EXTENSION IS IMPLANTED. NO FURTHER COMPLICATIONS WERE REPORTED OR ANTICIPATED WITH THIS EVENT.

    Description of Event or Problem · 1

    FOLLOW UP INFORMATION RECEIVED FROM THE HEALTHCARE PROFESSIONAL (HCP) REPORTED THAT THEY PLAN TO EXPLORE THE LEAD EXTENDER FOR THE HIGH IMPEDANCE/ERROR MESSAGES AND EXTENSION PROTRUDING ISSUE AT THE TIME THE PATIENT¿S INS NEEDED TO BE REPLACED. THE INS REMAINED IMPLANTED AT THE TIME OF REPORT UNTIL THE TIME IN NEEDS TO BE REPLACED. THERE WERE NO FURTHER COMPLICATIONS REPORTED OR ANTICIPATED.

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION WAS RECEIVED FROM THE PATIENT INDICATING THAT SOMETHING IS NOT RIGHT WITH HER IMPLANT AND THE DOCTOR HAS PLANS TO CHANGE IT AND SHE IS COMING TO THE OFFICE ON THURSDAY (B)(6) 2018 FOR EVALUATION. SHE ALSO STATED THAT THE LEADS WERE MOVED FROM HER CHEST TO HER STOMACH AND THAT HER DOCTOR SAID WHAT'S HAPPENING RIGHT NOW TO HER DEVICE IS SOMETHING UNUSUAL. THE PATIENT IS REFERRING TO HER EXTENSIONS AS THOSE ARE LOCATED IN THE CHEST, NOT THE LEADS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    54256 ACTIVA STIMULATOR, ELECTRICAL, IMPLANTED, FOR PARKINSONIAN TREMOR MHY MEDTRONIC PUERTO RICO OPERATIONS CO. 37601 00643169529786

    Patients

    Seq Age Sex Outcome Treatment
    1 70 YR Required Intervention