BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PERCEPT

    MDR report key: 13980943 · Received April 1, 2022

    Report

    Report Number
    3004209178-2022-04155
    Event Type
    Malfunction
    Date Received
    April 1, 2022
    Date of Event
    January 25, 2021
    Report Date
    April 5, 2022
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO.
    Product Code
    MHY
    UDI-DI
    00763000253363
    PMA / PMN Number
    P960009
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NJ, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    CONCOMMITANT MEDICAL PRODUCTS: PRODUCT ID: 3387S-40, LOT# VA25RHC, IMPLANTED: (B)(6) 2020, PRODUCT TYPE: LEAD. PRODUCT ID: 3387S-40, LOT# VA263GC, IMPLANTED: (B)(6) 2020, PRODUCT TYPE: LEAD. OTHER RELEVANT DEVICE(S) ARE: PRODUCT ID: 3387S-40, SERIAL/LOT #: (B)(4), UBD: (B)(6) 2022, UDI#: (B)(4). PRODUCT ID: 3387S-40, SERIAL/LOT #: (B)(4), UBD: (B)(6) 2022, UDI#: (B)(4). IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Additional Manufacturer Narrative · 0

    CONTINUATION OF D10: PRODUCT ID 3387S-40 LOT# VA25RHC SERIAL# IMPLANTED: 2020-(B)(6) EXPLANTED: PRODUCT TYPE LEAD PRODUCT ID 3387S-40 LOT# VA263GC SERIAL# IMPLANTED: 2020-(B)(6) EXPLANTED: PRODUCT TYPE LEAD MEDTRONIC IS SUBMITTING THIS REPORT TO COMPLY WITH FDA REPORTING REGULATIONS UNDER 21 CFR PARTS 4 AND 803. 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 AND HAS PROVIDED AS MUCH RELEVANT INFORMATION AS IS AVAILABLE TO THE COMPANY AS OF THE SUBMISSION DATE OF THIS REPORT. THIS REPORT DOES NOT CONSTITUTE AN ADMISSION OR A CONCLUSION BY FDA, MEDTRONIC, OR ITS EMPLOYEES THAT THE DEVICE, MEDTRONIC, OR ITS EMPLOYEE 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 REGULATORY REPORTING. MEDTRONIC OBJECTS TO THE USE OF THESE WORDS AND OTHERS LIKE THEM 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. ANY REQUIRED FIELDS THAT ARE UNPOPULATED ARE BLANK BECAUSE THE INFORMATION IS CURRENTLY UNKNOWN OR UNAVAILABLE. 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

    INFORMATION WAS RECEIVED FROM A PATIENT VIA MANUFACTURER REPRESENTATIVE WHO WAS IMPLANTED WITH AN IMPLANTABLE NEUROSTIMULATOR (INS) FOR PARKINSONS DUAL AND DBS THERAPY INDICATIONS. IT WAS REPORTED THAT THE PATIENT'S LEFT LEAD HAD IMPEDANCES THAT ARE OVER 2,000 OHMS. CONTACT 0=2 ,155 CONTACT 1=2,115 CONTACT 2=2,041 CONTACT 3=2,108. NO KNOWN FACTORS LED TO THE ISSUE. THE ISSUE WAS NOT YET RESOLVED. NO SYMPTOMS REPORTED. ADDITIONAL INFORMATION WAS RECEIVED. IT WAS REPORTED THAT THE PATIENT WAS SEEN YESTERDAY, AND IMPEDANCE SHOWS: C0: 2096 OHMS C10: 2083 OHMS. THE CALLER REPORTED THE PHYSICIAN WANTED TO EXPLANT BOTH LEADS AND RE-IMPLANT NEW LEADS AS THE CURRENT LEADS ARE NOT IN OPTIMAL PLACEMENT/TARGET AND WITH IMPEDANCE ISSUE, PATIENT IS UNABLE TO HAVE ANY MRI SCAN.

    Description of Event or Problem · 0

    ADDITIONAL INFORMATION WAS RECEIVED FROM THE REP THAT THE CAUSE OF THE IMPEDANCE ISSUE WAS NOT DETERMINED. THE PHYSICIAN HAS TESTED THIS INDIVIDUAL FOR BENEFIT FROM DBS IN PAST APPOINTMENTS. THE SYMPTOM RELIEF DUE TO STIMULATION WAS MINIMAL. NOTHING CAN BE DONE AT THIS POINT TO RESOLVE THE ISSUE, AS SEVERAL DIFFERENT CONTACT CONFIGURATIONS HAVE BEEN ATTEMPTED. SURGERY HAS NOT YET BEEN PLANNED, BUT THE PATIENT IS BEING EVALUATED FOR SURGERY. THE HIGH IMPEDANCE HAS NOT RESOLVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1229148 PERCEPT MHY MEDTRONIC PUERTO RICO OPERATIONS CO. B35200 00763000253363

    Patients

    Seq Age Sex Outcome Treatment
    1 73 YR Female