BEUDAMED
    FDA Adverse Event Injury Summary report: N

    KINETRA

    MDR report key: 8752863 · Received July 2, 2019

    Report

    Report Number
    3007566237-2019-01446
    Event Type
    Injury
    Date Received
    July 2, 2019
    Date of Event
    August 1, 2007
    Report Date
    August 30, 2019
    Manufacturer
    MEDTRONIC NEUROMODULATION
    Product Code
    MHY
    PMA / PMN Number
    P960009
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    ID, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    B3: EXACT EVENT DATE IS NOT KNOWN. MONTH AND YEAR OF B3 ARE VALID. LEAD IMPLANT DATES (BELOW) ARE AN ESTIMATE. EXACT IMPLANT DATE IS NOT KNOWN, BUT MONTH AND YEAR ARE VALID. D11: PRODUCT ID 3387S-40 LOT# V026844 SERIAL# IMPLANTED: (B)(6) 2007 EXPLANTED: (B)(6) 2010PRODUCT TYPE LEAD PRODUCT ID 3387S-40 LOT# V023550 SERIAL# IMPLANTED: (B)(6) 2007 EXPLANTED: (B)(6) 2014 PRODUCT TYPE LEAD H6: PATIENT CODE C76143 NO LONGER APPLIES. ADDITIONAL REVIEW INDICATES THAT INFORMATION FROM MANUFACTURER¿S REPORT #3007566237-2019-01447 WAS ALREADY REPORTED IN THIS REPORT ( #3007566237-2019-01446). ANY ADDITIONAL INFORMATION REGARDING THAT EVENT WILL BE SUBMITTED AS A SUPPLEMENTAL SUBMISSION TO THIS REPORT. 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

    ADDITIONAL INFORMATION WAS RECEIVED FROM THE CONSUMER. FOLLOWING ATTEMPTS TO OBTAIN GOOD PROGRAMMING RESULTS FROM TWO NEUROLOGISTS WITH NO SUCCESS. THE SECOND NEUROLOGIST REALIZED SOMETHING WAS NOT RIGHT, AND REFERRED THE PATIENT TO A DIFFERENT HEALTH CARE PROVIDER (HCP) FOR TROUBLESHOOTING. IT WAS REPORTED THAT THE PATIENT WAS SEEN IN (B)(6) 2010 FOR DBS TROUBLESHOOTING. BASED ON THE FINDINGS FROM TROUBLESHOOTING, IT WAS SUSPECTED AND CONFIRMED WITH MRI THAT BOTH LEADS WERE MALPOSITIONED. IT WAS "PRETTY WELL DETERMINED" THERE WAS NO MALFUNCTION OF THE NEUROSTIMULATOR AS THEY WORKED QUITE WELL. THE LEFT LEAD WAS PLACED TOO LATERAL AND POSTERIOR, SO THE NEUROSURGEON PLACED IT ABOUT 2 MM MORE MEDIAL AND 3 MM MORE ANTERIOR, WHICH PRODUCED, BASED ON WRITING SAMPLES, VIRTUALLY COMPLETE TREMOR CONTROL AT 3 VOLTS WITHOUT ANY SIDE EFFECTS. ON (B)(6) 2010, THE LEFT LEAD WAS REVISED WITH NO SURGICAL COMPLICATIONS, GOOD HEALING, NO HEAD OR VOICE OR DISABLING BILATERAL HAND TREMOR. IMPEDANCES WERE NORMAL AFTER REVISION, AND THE PATIENT AND PHYSICIAN WERE PLEASED WITH THE OUTCOME OF THE LEFT LEAD REVISION. THE RIGHT LEAD WAS ALSO DETERMINED TO BE PLACED PRETTY LATERAL AND POSTERIOR; HOWEVER, AT THE TIME OF THE LEFT LEAD REVISION, THE PHYSICIAN DECIDED TO LET THE PATIENT DECIDE IF THE RIGHT LEAD WOULD BE REVISED AFTER PROGRAMMING HOW GOOD THE LASTING EFFECT WAS ON THE RIGHT SIDE. IT WAS NOTED THE PATIENT HAD LESS THAN ADEQUATE TREMOR CONTROL ON THE LEFT SIDE (RIGHT LEAD). IN 2014, THE RIGHT LEAD WAS REVISED AND PLACEMENT WAS CORRECTED.

    Additional Manufacturer Narrative · 1

    CONCOMITANT MEDICAL PRODUCTS: PRODUCT ID: 3387S-40, LOT #: UNKNOWN, IMPLANTED: (B)(6) 2007, PRODUCT TYPE: LEAD. OTHER RELEVANT DEVICE(S) ARE: PRODUCT ID: 3387S-40, SERIAL/LOT #: UNKNOWN. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Description of Event or Problem · 1

    INFORMATION WAS RECEIVED FROM A CONSUMER REGARDING A PATIENT WITH AN IMPLANTABLE NEUROSTIMULATOR (INS). THE RIGHT AND LEFT "PROBE PLACEMENT" WAS IN AUGUST 2007 WITH A DUAL PORT. IN 2010 THE LEFT SIDE PROBE PLACEMENT WAS CORRECTED, GIVING MUCH BETTER RESULTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    546869 KINETRA STIMULATOR, ELECTRICAL, IMPLANTED, FOR PARKINSONIAN TREMOR MHY MEDTRONIC NEUROMODULATION 7428

    Patients

    Seq Age Sex Outcome Treatment
    1 58 YR Required Intervention "SEE H10..."| "SEE H10...."