BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACTIVA

    MDR report key: 8156913 · Received December 12, 2018

    Report

    Report Number
    3004209178-2018-27500
    Event Type
    Malfunction
    Date Received
    December 12, 2018
    Date of Event
    December 7, 2018
    Report Date
    February 1, 2019
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO.
    Product Code
    MHY
    UDI-DI
    00613994934604
    PMA / PMN Number
    P960009
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AZ, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    MEDTRONIC, INC. (MEDTRONIC) IS SUBMITTING THIS REPORT TO COMPLY WITH 21 C.F.R. PART 803, THE MEDICAL DEVICE REPORTING REGULATION. THIS REPORT IS BASED UPON INFORMATION OBTAINED BY MEDTRONIC, WHICH THE COMPANY MAY NOT HAVE BEEN ABLE TO FULLY INVESTIGATE OR VERIFY PRIOR TO THE DATE THE REPORT WAS REQUIRED BY THE FDA. MEDTRONIC HAS MADE REASONABLE EFFORTS TO OBTAIN MORE COMPLETE INFORMATION IN THE TIME ALLOTTED AND HAS PROVIDED AS MUCH INFORMATION AS IS AVAILABLE TO THE COMPANY AS OF THE SUBMISSION DATE THIS REPORT. THIS REPORT DOES NOT CONSTITUTE AN ADMISSION OR A CONCLUSION BY FDA, MEDTRONIC, OR ITS EMPLOYEES THAT THE DEVICE, MEDTRONIC OR ITS EMPLOYEES CAUSED OR CONTRIBUTED TO THE EVENT DESCRIBED IN THE REPORT. IN PARTICULAR, THIS REPORT DOES NOT CONSTITUTE AN ADMISSION BY ANYONE THAT THE PRODUCT DESCRIBED IN THIS REPORT HAS ANY "DEFECTS" OR HAS "MALFUNCTIONED". THESE WORDS ARE INCLUDED IN THE FDA 3500A FORM AND ARE FIXED ITEMS FOR SELECTION CREATED BY THE FDA, TO CATEGORIZE THE TYPE OF EVENT SOLELY FOR THE PURPOSE OF REPORTING PURSUANT TO PART 803. MEDTRONIC OBJECTS TO THE USE OF THESE WORDS AND OTHERS LIKE IT BECAUSE OF THE LACK OF DEFINITION AND THE CONNOTATIONS IMPLIED BY THESE TERMS. THIS STATEMENT SHOULD BE INCLUDED WITH ANY INFORMATION OR REPORT DISCLOSED TO THE PUBLIC UNDER THE FREEDOM OF INFORMATION ACT. 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.

    Description of Event or Problem · 0

    ADDITIONAL INFORMATION WAS RECEIVED FROM THE HEALTHCARE PROVIDER (HCP) REPORTING THAT THEY SAW THE PATIENT ON (B)(6) 2018 WHEN HER BATTERY WAS AT 2.55. THE PATIENT'S TREMOR WAS MINIMAL ON EXAM. THEREFORE, COMBINED WITH HER OTHER EXAM, THEY THINK THE CAUSE OF HER RETURN OF TREMOR WAS NOT DUE TO DBS BATTERY. THE BATTERY WAS REPLACED AND THEY DO NOT THINK HER BATTERY HAS HAD LOSS OF THERAPY OF DBS. THE PATIENT HAD HER HEAD CT ON (B)(6) 2018 SUGGESTING DEVELOPMENT OF OSSEOUS EROSION SURROUNDING THE DBS ENTRY SIT IN THE RIGHT CALVARIUM WITH ADJACENT LUCENCY. MRI BRAIN ARRANGED BUT THE PATIENT DID NOT DO IT. FOLLOW-UP CALL TO THE PATIENT AND THEY WERE TOLD THEY SAW OTHER NEUROLOGIST.

    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 (HCP) REGARDING A PATIENT'S IMPLANTABLE NEUROSTIMULATOR (INS) FOR THE TREATMENT OF PARKINSON¿S DUAL AND MOVEMENT DISORDERS. THE CALLER WAS THE DOCTOR IN THE ER AND INDICATED THE PATIENT HAD A REPLACEMENT SURGERY SCHEDULED FOR (B)(6) 2018 BUT LOST THERAPY ON (B)(6) 2018. THE DOCTOR WAS UNABLE TO CHECK INS FOR EOS OR ON/OFF STATUS AT THE TIME OF THE CALL. IT WAS REPORTED THE PATIENT HAD TREMORS THAT BEGAN SUDDENLY. THE CALLER WAS INSTRUCTED TO CONTACT THE MANAGING HEALTH CARE PROFESSIONAL (HCP) WITH THE STATUS OF THE INS. IT WAS NOTED THE PATIENT SAW THE MANAGING HCP ON (B)(6) 2018. NO FURTHER COMPLICATIONS WERE REPORTED OR ANTICIPATED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    996600 ACTIVA STIMULATOR, ELECTRICAL, IMPLANTED, FOR PARKINSONIAN TREMOR MHY MEDTRONIC PUERTO RICO OPERATIONS CO. 37601 00613994934604

    Patients

    Seq Age Sex Outcome Treatment
    1 78 YR