BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    KINETRA

    MDR report key: 2536503 · Received April 16, 2012

    Report

    Report Number
    3004209178-2012-02377
    Event Type
    Malfunction
    Date Received
    April 16, 2012
    Report Date
    March 30, 2012
    Manufacturer
    MEDTRONIC MED REL MEDTRONIC PUERTO RICO
    Product Code
    MHY
    PMA / PMN Number
    P960009
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    PRODUCT ID 748240, SERIAL# (B)(4), IMPLANTED: (B)(6) 2008, PRODUCT TYP EXTENSION PRODUCT ID 7436, SERIAL# (B)(4), IMPLANTED: (B)(6) 2010, PRODUCT TYP PROGRAMMER, PATIENT PRODUCT ID 3387S-40, LOT# V171221, IMPLANTED: (B)(6) 2008, PRODUCT TYP LEAD. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT WAS EXPERIENCING A SHOCKING OR JOLTING SENSATION AND A LOSS OF THERAPEUTIC EFFECT WITH A PARTIAL LOSS OF BENEFIT. THE PATIENT HAD ALWAYS HAD ISSUES GETTING SATISFACTORY STIM THERAPY SINCE HE FIRST WAS IMPLANTED. THERE WAS NO KNOWN ACCIDENT OR INCIDENT RELATED TO THIS ISSUE. REVIEWED CURRENT IMPEDANCE MEASUREMENTS WERE NORMAL. IMPEDANCE TAKEN AT 4V: C0=741, C1=??, C2=736, C3=741; 01=741; 02=932; 03=1250; 12=??, 13=932, 23=932. THERAPY IMPED = 347 OHMS WITH 237 CURRENT. REVIEWED THIS WAS A LOWER IMPEDANCE LEVEL THAN TYPICALLY SEEN WITH 7428'S. SETTINGS ARE 3-, 2+1-,0+, 4.7V, 120, 155HZ AND BATTERY VOLTAGE AT 2.48 V TODAY. REVIEWED THAT HIGHER THAN AVERAGE SETTINGS MAY BE CONTRIBUTING TO THE LOW IMPEDANCE AND HIGH CURRENT LEVEL. THE PATIENT HAD VIM IMPLANT FOR ET (ESSENTIAL TREMOR). SHOCKING WAS FELT WITH STIM OFF AS WELL. REVIEWED THAT IMPEDANCE GENERALLY APPEARED TO BE NORMAL RANGE, THOUGH THERE WERE TWO ELECTRODE PAIRS WITHOUT AN OHMS READING. THEY WERE GOING TO TRY TO DO SOME REPROGRAMMING WITH THE PATIENT. IT WAS BELIEVED THERE HAD BEEN IMAGING OF SYSTEM DONE IN THE PAST, BUT THAT THEY WERE NEGATIVE, BUT THEY WERE NOT POSITIVE. IF ADDITIONAL INFORMATION IS RECEIVED, A FOLLOW UP REPORT WILL BE SENT.

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION RECEIVED REPORTED THAT THE PATIENT SOMETIMES EXPERIENCED A "SHOCKING SENSATION AT BATTERY SITE". IT WAS NOTED THAT THE DEVICE IMPEDANCE WAS MEASURED ON (B)(6) 2012 AND REVEALED LOW IMPEDANCE VALUES. IT WAS FURTHER NOTED THAT IMAGING WAS PERFORMED ON (B)(6) 2011 AND NO CHANGE IN THE LEADS WERE DETERMINED. THE PHYSICIAN STATED THAT THE PATIENT HAD BEEN REPROGRAMMED MULTIPLE TIMES AND FREQUENTLY DUE TO THE RETURN OF HIS TREMORS. THE PHYSICIAN STATED THAT IT WAS UNKNOWN IF THE PATIENT HAD BEEN HOSPITALIZED. NO PATIENT INJURY WAS REPORTED AND THE EVENT WAS DEEMED AS "NON-SERIOUS".

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION RECEIVED NOTED THAT REGARDING DIAGNOSTICS, IMPEDANCE MEASUREMENTS WERE TAKEN AND APPEARED TO BE WITHIN NORMAL RANGES. RE-PROGRAMMING WAS PERFORMED WITH MINIMAL TO MODERATE IMPROVEMENT IN TREMOR CONTROL. THIS WAS DONE ON 2012-(B)(6). NO DEVICE MALFUNCTIONS COULD BE DETECTED. INTERVENTIONS WERE NOTED AS N/A. REGARDING THE PATIENT'S OUTCOME IT WAS NOTED TREMOR CONTROL LASTS BRIEFLY (HOURS TO A FEW DAYS) AFTER RE-PROGRAMMING. THIS REPORTER HAD NOT SEEN THE PATIENT SINCE 2012-(B)(6) REGARDING THIS MATTER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 KINETRA STIMULATOR, ELECTRICAL, IMPLANTED, FOR PARKINSONIAN TREMOR MHY MEDTRONIC MED REL MEDTRONIC PUERTO RICO 7428

    Patients

    Seq Age Sex Outcome Treatment
    1