BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ACTIVA

    MDR report key: 7823069 · Received August 28, 2018

    Report

    Report Number
    3004209178-2018-19318
    Event Type
    Injury
    Date Received
    August 28, 2018
    Date of Event
    February 18, 2018
    Report Date
    October 24, 2018
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO.
    Product Code
    MHY
    UDI-DI
    00643169529786
    PMA / PMN Number
    P960009
    Removal / Correction Number
    Z-1617-2015
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

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

    Additional Manufacturer Narrative · 1

    SECTION 'SUSPECT DEVICE' INFORMATION REFERENCES THE MAIN COMPONENT OF THE SYSTEM AND OTHER APPLICABLE COMPONENTS ARE : PRODUCT ID: 3708660, SERIAL# UNKNOWN, IMPLANTED: (B)(6) 2016, EXPLANTED: (B)(6) 2018, PRODUCT TYPE: EXTENSION. 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

    NO INFORMATION FOR DATE OF EVENT. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Additional Manufacturer Narrative · 1

    ANALYSIS OF THE EXTENSION (SERIAL # (B)(4)) REVEALED THAT THE CONDUCTOR BODY WAS BROKEN LESS THAN 5CM FROM THE PROXIMAL END. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Additional Manufacturer Narrative · 1

    PRODUCT ID: 3708660, SERIAL# (B)(4), IMPLANTED: (B)(6) 2016, EXPLANTED: (B)(6) 2018, PRODUCT TYPE: EXTENSION. ANALYSIS RESULTS WERE NOT AVAILABLE AS OF THE DATE OF THIS REPORT. A FOLLOW-UP REPORT WILL BE SUBMITTED WHEN ANALYSIS IS COMPLETE. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION WAS RECEIVED: IT WAS REPORTED THAT THEY HAD NO OTHER INFORMATION OTHER THAN THE IMPEDANCES WERE HIGH. IMPEDANCES WERE CHECKED BY THE DOCTOR AND THEY WERE HOPING THAT REPLACING THE EXTENSIONS WOULD CORRECT THE PROBLEM. THE SURGERY IS STILL SCHEDULED FOR (B)(6) 2018. THERE WERE NO FURTHER COMPLICATIONS REPORTED.

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION WAS RECEIVED FROM A HEALTHCARE PROVIDER (HCP)VIA MANUFACTURE REPRESENTATIVE (REP) INDICATING THAT THERE WERE HIGH IMPEDANCES ON CONTACT 10 SEEN IN THE OFFICE IN (B)(6) 2018. REVISION WAS SCHEDULED FOR (B)(6) 2018. IMPEDANCES CHECKED PRE-OP AND REMAINED HIGH ON CONTACT 10. IMPEDANCES CHECKED AT ALL VOLTS (.7, 1.5 AND 3.0) CONTACT 10 AND 11 STILL REMAINED HIGH - GREATER THAN 40000. THE DOCTOR DECIDED TO REPLACE EXTENSION, AND ALL IMPEDANCES ARE WITHIN NORMAL RANGE. THE ISSUE WAS RESOLVED AT THE TIME OF THE REPORT. NO KNOWN PATIENT OR EXTERNAL FACTORS THAT MAY HAVE LED OR CONTRIBUTED TO THE ISSUE WERE REPORTED.

    Description of Event or Problem · 1

    FURTHER INFORMATION WAS RECEIVED FROM A MANUFACTURER REPRESENTATIVE (REP) REITERATING THE REVISION FOR HIGH IMPEDANCES ON SOME CONTACTS. THEY REPORT THAT THE HEALTHCARE PROVIDER LOOKED AT THE EXTENSION FIST. LONGEVITY ESTIMATE DONE USING L 3.5V 120 RATE 90PW 1066 C+2- AND RIGHT 3V 120 HZ 90PW 759 OHMS WITH BAT SHOWING 2.89V REVIEWED ERI 3Y AND EOS AT 3.2 YEARS. CALLER REPORTED THEY ARE NOT USING THE AFFECTED CONTACTS. HIGH IMPEDANCE ON RIGHT SIDE. C AND 8, 10, 33192 8 11 >40K. HIGH IMPEDANCES WERE NOTICED BY THE SURGEON WHEN THE PATIENT WAS IN THE OFFICE IN (B)(6) AND FOUND THE HIGH IMPEDANCES.

    Description of Event or Problem · 1

    INFORMATION WAS RECEIVED FROM A HEALTHCARE PROVIDER (HCP) VIA A MANUFACTURER REPRESENTATIVE (REP) REGARDING A PATIENT WHO WAS IMPLANTED WITH A NEUROSTIMULATOR (INS) FOR PARKINSON'S DUAL AND MOVEMENT DISORDERS. IT WAS REPORTED THAT THE REP WAS ADVISED VIA EMAIL THAT THE PATIENT IS SCHEDULED FOR POSSIBLE REVISION ON (B)(6) 2018 FOR POTENTIAL OPEN CIRCUIT. THEY DO NOT HAVE ANY ADDITIONAL INFORMATION AT THIS TIME. UNKNOWN IF ANY ENVIRONMENTAL/EXTERNAL/PATIENT FACTORS THAT MAY HAVE LED OR CONTRIBUTED TO THE ISSUE. UNKNOWN IF ANY DIAGNOSTICS/TROUBLESHOOTING WAS DONE. THE ISSUE IS NOT YET RESOLVED. SURGICAL INTERVENTION IS PLANNED FOR (B)(6) 2018. NO FURTHER COMPLICATIONS WERE REPORTED OR ANTICIPATED WITH THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    662862 ACTIVA STIMULATOR, ELECTRICAL, IMPLANTED, FOR PARKINSONIAN TREMOR MHY MEDTRONIC PUERTO RICO OPERATIONS CO. 37601 00643169529786

    Patients

    Seq Age Sex Outcome Treatment
    1 82 YR Required Intervention