BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ACTIVA

    MDR report key: 7565857 · Received June 4, 2018

    Report

    Report Number
    3004209178-2018-12490
    Event Type
    Injury
    Date Received
    June 4, 2018
    Date of Event
    May 31, 2018
    Report Date
    December 18, 2018
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO.
    Product Code
    MHY
    UDI-DI
    00643169100770
    PMA / PMN Number
    P960009
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AL, 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

    CONTINUATION: PRODUCT ID 3708660 SERIAL(B)(6) IMPLANTED: (B)(6)2012 PRODUCT TYPE EXTENSION PRODUCT ID 3708660 SERIAL(B)(4) IMPLANTED: (B)(6)2012 PRODUCT TYPE EXTENSION PRODUCT ID 3387-40 LOT# J0114054V IMPLANTED:(B)(6)2001 PRODUCT TYPE LEAD PRODUCT ID 3387-40 J0225645V IMPLANTED: (B)(6)2002 PRODUCT TYPE LEAD PRODUCT ID 3387-40 LOT# J0225645V IMPLANTED(B)(6)2002 PRODUCT TYPE LEAD PRODUCT ID 3387-40 LOT# J0225645V PRODUCT TYPE LEAD DUE TO IMDRF HARMONIZATION, SOME PREVIOUSLY SUBMITTED DEVICE, METHOD, RESULT, AND CONCLUSION CODES RELATED TO THIS EVENT MAY HAVE BEEN UPDATED. MEDTRONIC, INC. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Additional Manufacturer Narrative · 1

    CONTINUATION OF MEDICAL DEVICES: PRODUCT ID 3708660, SERIAL# (B)(4), IMPLANTED: (B)(6) 2012, PRODUCT TYPE EXTENSION. PRODUCT ID 3708660, SERIAL# (B)(4), IMPLANTED: (B)(6) 2012, PRODUCT TYPE EXTENSION. PRODUCT ID 3387-40, LOT# J0114054V, IMPLANTED: (B)(6) 2001, PRODUCT TYPE LEAD. PRODUCT ID 3387-40, LOT# J0225645V IMPLANTED: (B)(6) 2002 PRODUCT TYPE LEAD. PRODUCT ID 3387-40, LOT# J0225645V IMPLANTED: (B)(6) 2002 PRODUCT TYPE LEAD. PRODUCT ID 3387-40, LOT# J0225645V PRODUCT TYPE LEAD. INFORMATION REFERENCES THE MAIN COMPONENT OF THE SYSTEM. OTHER RELEVANT DEVICE(S) ARE: PRODUCT ID: 3708660, SERIAL/LOT #: (B)(4), UBD: 10-SEP-2016, UDI#: (B)(4); PRODUCT ID: 3708660, SERIAL/LOT #: (B)(4), UBD: 10-SEP-2016, UDI#: (B)(4); PRODUCT ID: 3387-40, SERIAL/LOT #: (B)(4), UBD: 24-JUL-2005, UDI#: (B)(4); PRODUCT ID: 3387-40, SERIAL/LOT #: (B)(4), UBD: 16-SEP-2006, UDI#: (B)(4); PRODUCT ID: 3387-40, SERIAL/LOT #: (B)(4), UBD: 16-SEP-2006, UDI#: (B)(4); PRODUCT ID: 3387-40, SERIAL/LOT #: (B)(4), UBD: 16-SEP-2006, UDI#: (B)(4). IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Additional Manufacturer Narrative · 1

    ANALYSIS RESULTS WERE NOT AVAILABLE AT THE TIME OF THIS REPORT. A FOLLOW-UP REPORT WILL BE SENT WHEN ANALYSIS IS COMPLETE. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Additional Manufacturer Narrative · 1

    ANALYSIS OF THE IMPLANTABLE NEUROSTIMULATOR REVEALED NO ANOMALY. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION WAS RECEIVED FROM THE HEALTHCARE PROFESSIONAL VIA THE MANUFACTURER REPRESENTATIVE STATING THE CAUSE OF THE SHOCKING WAS NOT YET DETERMINED. NO ACTION/INTERVENTIONS WERE TAKEN YET. THE SHOCKING HAD NOT BEEN RESOLVED AT THE TIME OF THE REPORT.

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION WAS RECEIVED FROM THE HCP VIA THE REP STATING THE DEVICE WAS EXPLANTED AND REPLACED WITH A NEW IMPLANT. IT WAS REPORTED THE PATIENT SYMPTOMS HAD RESOLVED.

    Description of Event or Problem · 1

    INFORMATION WAS RECEIVED FROM A HEALTHCARE PROFESSIONAL VIA A MANUFACTURER REPRESENTATIVE REGARDING A PATIENT WITH AN IMPLANTABLE NEUROSTIMULATOR (INS). IT WAS REPORTED THE PATIENT EXPERIENCED SHOCKING IN THE ARM. IT WAS UNKNOWN IF ANY ENVIRONMENTAL FACTORS LED OR CONTRIBUTED TO THE ISSUE AND IT WAS UNKNOWN IF TROUBLESHOOTING/INTERVENTIONS HAD BEEN PERFORMED. THE ISSUE WAS NOT RESOLVED AT THE TIME OF THE REPORT. SURGICAL INTERVENTION DID NOT OCCUR AND WAS NOT PLANNED. THE PATIENT WAS ALIVE WITHOUT INJURY AT THE TIME OF THE REPORT. NO FURTHER COMPLICATIONS WERE REPORTED OR ANTICIPATED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    406919 ACTIVA STIMULATOR, ELECTRICAL, IMPLANTED, FOR PARKINSONIAN TREMOR MHY MEDTRONIC PUERTO RICO OPERATIONS CO. 37601 00643169100770

    Patients

    Seq Age Sex Outcome Treatment
    1 66 YR Required Intervention