BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ACTIVA

    MDR report key: 7210965 · Received January 22, 2018

    Report

    Report Number
    3004209178-2018-01149
    Event Type
    Injury
    Date Received
    January 22, 2018
    Date of Event
    January 1, 2015
    Report Date
    February 12, 2018
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO.
    Product Code
    MHY
    UDI-DI
    00643169529786
    PMA / PMN Number
    P960009
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    OTHER APPLICABLE COMPONENTS ARE: PRODUCT ID: 37601, SERIAL# (B)(4), IMPLANTED: (B)(6) 2017, PRODUCT TYPE: IMPLANTABLE NEUROSTIMULATOR. PRODUCT ID: 37601, SERIAL# (B)(4), IMPLANTED: (B)(6) 2013, EXPLANTED: (B)(6) 2016, 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. [REFER TO MANUFACTURER REPORT #3004209178-2018-01144 AND 3004209178-2018-01145 FOR DETAILS PERTAINING TO THE REPORTABLE RELATED EVENT]. 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

    BASED ON FURTHER REVIEW OF THE FILE, PARTS OF THIS EVENT WERE REPORTED IN MANUFACTURER¿S REPORT 3004209178-2017-10306. ALL ADDI TIONAL/FOLLOW UP INFORMATION WILL BE REPORTED UNDER THAT REPORT. 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.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    54907 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