BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SOLETRA

    MDR report key: 3173678 · Received June 17, 2013

    Report

    Report Number
    3004209178-2013-10460
    Event Type
    Malfunction
    Date Received
    June 17, 2013
    Report Date
    May 29, 2013
    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
    WV, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    PRODUCT ID: 7482A51, SERIAL# (B)(4), IMPLANTED: 2009, PRODUCT TYPE: EXTENSION. PRODUCT ID 3387S-40. LOT# V054604. IMPLANTED: 2009, PRODUCT TYPE: LEAD. PRODUCT ID: 7438, SERIAL# (B)(4) , PRODUCT TYPE: PROGRAMMER. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT OUT OF THE BLUE, A COUPLE DAYS PRIOR TO THE DATE OF THIS REPORT THE PATIENT¿S HAND STARTED TO SHAKE REAL BAD. THE PATIENT COULD NOT EVEN WRITE HER NAME LEGIBLY AND HAD DIFFICULTY EATING. IT WAS ALSO REPORTED THAT THE PATIENT HAD BEEN HAVING TROUBLE READING SMALL PRINT, BUT IT WAS THOUGHT TO BE DUE TO AGING. THERE WAS NO KNOWN ACCIDENT OR INCIDENT RELATED TO THIS. THE IMPLANTABLE PULSE GENERATOR (IPG) HAD NOT BEEN CHECKED WITH A CLINICIAN PROGRAMMER FOR ABOUT TWO YEARS. IT WAS REPORTED THAT A NEW BATTERY WAS PUT IN THE PATIENT PROGRAMMER, BUT IT WASN¿T WORKING. WHEN THE BUTTON TO TURN IT ON OR OFF WAS PRESSED, IT USUALLY BEEPED; HOWEVER, ON THE DATE OF THIS REPORT ¿IT WOULD NOT DO ANYTHING¿ THOUGH THE LIGHT WOULD COME ON. THE PATIENT PROGRAMMER WAS CHECKED, BUT IT PASSED THE SELF-TEST. IT WAS THOUGHT THAT THERE WAS PROBABLY AN ISSUE WITH THE BATTERY IN THE IPG. ADDITIONAL INFORMATION HAS BEEN REQUESTED, BUT WAS NOT AVAILABLE AS OF THE DATE OF THIS REPORT.

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION STATED THE PATIENT¿S IMPLANTABLE NEUROSTIMULATOR (INS) WAS REPLACED ON (B)(6) 2013. IT WAS STATED THE BATTERY ¿HAD REACHED THE END OF ITS NORMAL LIFE.¿ IT WAS NOTED THE SURGERY WAS ¿PERFORMED WITH NO ISSUES¿ AND THE PATIENT WAS DISCHARGED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    273726 SOLETRA STIMULATOR, ELECTRICAL, IMPLANTED, FOR PARKINSONIAN TREMOR MHY MEDTRONIC MED REL MEDTRONIC PUERTO RICO 7426

    Patients

    Seq Age Sex Outcome Treatment
    1 00065 YR