BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ACTIVA

    MDR report key: 8056453 · Received November 9, 2018

    Report

    Report Number
    3004209178-2018-25130
    Event Type
    Injury
    Date Received
    November 9, 2018
    Date of Event
    November 7, 2018
    Report Date
    May 22, 2019
    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
    IN, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    UPDATED TO INCLUDE HOSPITALIZATION. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Additional Manufacturer Narrative · 1

    CONCOMITANT MEDICAL PRODUCTS: PRODUCT ID: 3387S-40, LOT# VA1Q5CU, IMPLANTED: (B)(6) 2018, EXPLANTED: (B)(6) 2018, PRODUCT TYPE: LEAD. OTHER RELEVANT DEVICE(S) ARE: PRODUCT ID: 3387S-40, SERIAL/LOT #: VA1Q5CU, UBD: 06-FEB-2021, (B)(4). IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Additional Manufacturer Narrative · 1

    PRODUCT ID: NEU_STIMLOC_ACC, LOT# UNKNOWN, PRODUCT TYPE: ACCESSORY; PRODUCT ID: 3387S-40, LOT# VA1Q5CU, IMPLANTED: (B)(6) 2018, EXPLANTED: (B)(6) 2018, PRODUCT TYPE: LEAD; PRODUCT ID: A610, SERIAL# UNKNOWN, PRODUCT TYPE: SOFTWARE. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Additional Manufacturer Narrative · 1

    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.

    Additional Manufacturer Narrative · 1

    ANALYSIS OF THE LEAD (LOT# VA1Q5CU) DETERMINED THAT THE LEAD BODY CONDUCTOR HAD A SHORT BETWEEN CIRCUITS (OVERSTRESS/DAMAGE). 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 VIA A MANUFACTURER REPRESENTATIVE (REP) REGARDING A PATIENT WHO WAS IMPLANTED WITH A NEUROSTIMULATOR (INS) FOR ESSENTIAL TREMOR AND MOVEMENT DISORDERS. IT WAS REPORTED THAT THE PATIENT HAD AN INFECTION ON SCALP AROUND RIGHT HEMISPHERE INCISION. UNKNOWN IF ANY ENVIRONMENTAL/EXTERNAL/PATIENT FACTORS THAT MAY HAVE LED OR CONTRIBUTED TO THE ISSUE. DIAGNOSTICS/TROUBLESHOOTING INVOLVED A PATHOLOGY REPORT AT CHS. INTERVENTIONS/ACTIONS INCLUDED ANTIBIOTICS PRESCRIBED AND THE RIGHT LEAD EXPLANT IS PLANNED. THE ISSUE IS NOT YET RESOLVED. THE SURGICAL INTERVENTION IS PLANNED FOR (B)(6) 2018. IT IS UNKNOWN IF THE DEVICE WILL BE RETURNED FOR ANALYSIS. HIGH IMPEDANCES WERE ALSO NOTED ON THE RIGHT LEAD ON C11=2265, C10=2175, AND 10-11=4118. NO FURTHER COMPLICATIONS WERE REPORTED OR ANTICIPATED WITH THIS EVENT.

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION WAS RECEIVED FROM THE HEALTH CARE PROFESSIONAL (HCP) VIA A MANUFACTURE REPRESENTATIVE (REP). IT WAS REPORTED THE PATIENT HAD A SCALP INFECTION. THE CAUSE OF THE ISSUE WAS NOT REPORTED. IMPEDANCES WERE WITHIN NORMAL LIMITS AND THE HCP REPORTED EFFICACY WAS ACHIEVED. THE SYSTEM WAS REMOVED DUE TO THE INFECTION. THE ISSUE WAS RESOLVED AT THE TIME OF THE REPORT. THE PATIENT WAS ALIVE WITHOUT INJURY AT THE TIME OF THE REPORT.

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION WAS RECEIVED FROM THE MANUFACTURER REPRESENTATIVE (REP) INDICATING THAT THE CAUSE OF THE HIGH IMPEDANCES WAS NOT DETERMINED. THE LIMITS WERE BARELY OUTSIDE NORMAL LIMITS AND IF THE NEW TABLET PROGRAMMER HAD THE ABILITY TO INCREASE VOLTAGE OF THE IMPEDANCE TESTS THEY ARE CONFIDENT THAT ALL IMPEDANCES WOULD'VE BEEN WITHIN NORMAL LIMIT. THE HIGH IMPEDANCES WERE RESOLVED WITH THE EXPLANT OF THE RIGHT LEAD. THEY DON'T THINK THE INFECTION HAS BEEN RESOLVED, SINCE THE SURGEON SAID THAT THE PATIENT WILL REMAIN IN HOSPITAL ON IV ANTIBIOTICS. ALL LEFT SIDE IMPEDANCES WERE WITH NORMAL LIMIT. THE RIGHT LEAD WAS EXPLANTED AND THE REP RETURNED THE DEVICE FOR ANALYSIS. THE SURGEON WANTED TO REITERATE THAT THE EXPLANT WAS FOR THE INFECTION AND IT WAS NOT A PRODUCT ISSUE. THIS INFORMATION HAS BEEN CONFIRMED WITH THE PHYSICIAN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    894461 ACTIVA STIMULATOR, ELECTRICAL, IMPLANTED, FOR PARKINSONIAN TREMOR MHY MEDTRONIC PUERTO RICO OPERATIONS CO. 37601 00643169529786

    Patients

    Seq Age Sex Outcome Treatment
    1 67 YR Hospitalization| R