BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACTIVA

    MDR report key: 3072990 · Received April 23, 2013

    Report

    Report Number
    3004209178-2013-06762
    Event Type
    Malfunction
    Date Received
    April 23, 2013
    Report Date
    September 4, 2013
    Manufacturer
    MEDTRONIC MED REL MEDTRONIC PUERTO RICO
    Product Code
    MRU
    PMA / PMN Number
    H020007
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MA, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Additional Manufacturer Narrative · 1

    CONCOMITANT PRODUCTS: PRODUCT ID 3387S-40, LOT# V095358, IMPLANTED: (B)(6) 2008, PRODUCT TYPE LEAD; PRODUCT ID 3387S-40, LOT# V095358, IMPLANTED: (B)(6) 2008, PRODUCT TYPE LEAD; PRODUCT ID 7482A51, SERIAL# (B)(4), IMPLANTED: (B)(6) 2008, PRODUCT TYPE EXTENSION; PRODUCT ID 7482A51, SERIAL# (B)(4), IMPLANTED: (B)(6) 2008, PRODUCT TYPE EXTENSION; PRODUCT ID 37092, LOT# 310970001, IMPLANTED: (B)(6) 2012, PRODUCT TYPE ACCESSORY; PRODUCT ID 64002, LOT# N300694, IMPLANTED: (B)(6) 2012, PRODUCT TYPE ADAPTER; PRODUCT ID 37642, SERIAL# (B)(4), IMPLANTED: (B)(6) 2012, PRODUCT TYPE PROGRAMMER, PATIENT. (B)(4).

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION RECEIVED REPORTED THAT THE CAUSE OF THE EVENT WAS UNKNOWN. IT WAS NOTED THAT REPROGRAMMING WAS DONE ON (B)(6) 2013 AND ATTEMPTS WERE MADE TO MAKE CHANGES IN VOLTAGE OR PULSE WIDTH OR RATE. HOWEVER, THE PATIENT REPORTED MORE DISCOMFORT, THUS THE SETTINGS WERE RETURNED TO PREVIOUS (B)(6) SETTINGS. IT WAS NOTED PATIENT DID NOT REQUIRE HOSPITALIZATION AND THERE WAS NO INJURY.

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION RECEIVED REPORTED THAT THE CAUSE OF THE EVENT WAS A SUPERIMPOSED THROAT INFECTION AND NO COMPONENT OF THE DEVICE SYSTEM WAS INVOLVED. IT WAS NOTED THAT THE EVENT HAD NOTHING TO DO WITH THE DEVICE SYSTEM. SIGNS AND SYMPTOMS OF THE EVENT INCLUDED INCREASED ARM AND FACE MOVEMENTS. IT WAS NOTED THAT THE PATIENT DID NOT REQUIRE HOSPITALIZATION.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A PATIENT HAD A NEW ONSET OF SYMPTOMS AFFECTING HIS RIGHT SIDE. THE REPORTER STATED THAT AN INTERROGATION OF THE PATIENT'S SYSTEM REVEALED AN ABNORMALITY IN THE CASE AND ZERO CONTACT PAIR WHICH SAID THAT IT WAS READING HIGH. IT WAS NOTED THAT A FEW MONOPOLAR ELECTRODE CONTACT PAIRS HAD VALUES GREATER THAN 2000 OHMS. IT WAS REPORTED THAT SUNDAY PRIOR TO THE REPORT THE PATIENT NOTED A SUDDEN ONSET OF PAIN AND SOME TENDERNESS IN THE RIGHT POSTERIOR AREA OF THE HEAD WHERE THE ELECTRODES WERE CONNECTED TO THE EXTENSIONS AND THERE WAS AN ONSET OF SPASMS IN THE RIGHT FACE, RIGHT ARM, AND RIGHT LEG AND SOME INVERSION OF THE RIGHT FOOT. IT WAS NOTED THAT THE PAIN WAS INTERMITTENT. IT WAS REPORTED THAT THE PATIENT HAD A GENERAL SENSE OF DISCOMFORT AND 'NOT FEELING RIGHT" BUT THE PATIENT DIDN'T APPEAR TO BE CONTINUALLY CONTRACTED. THE REPORTER STATED THAT A MONTH OR TWO PRIOR TO THE REPORT THE PATIENT HAD AN EVENT IN WHICH HE FELT SUDDEN PAIN AT THE LEAD AND EXTENSION SITE AND WAS SEEN AT A LOCAL HOSPITAL. IT WAS REPORTED THAT AN INTERROGATION OF THE SYSTEM WAS DONE AND THEY DECIDED AT THE TIME THAT THE PAIN WAS RELATED TO SCAR TISSUE IN THE AREA. IT WAS NOTED THAT THE PATIENT HAD PARTIAL SYMPTOM CONTROL. THE REPORTER STATED THAT THE PATIENT HAD DYSTONIC MUSCLE SPASMS PRIOR TO IMPLANT, WAS REPROGRAMMED A MONTH PRIOR TO THE REPORT, AND HAD BEEN DOING 'REALLY WELL' UNTIL SUNDAY. IT WAS REPORTED THAT PRIOR TO A MONTH AGO THE PATIENT HAD SOME BACK SPASMS AND WITH THE REPROGRAMMING THEY HAD IMPROVED. THE REPORTER STATED THAT SOME PROGRAMMING CHANGES WERE TRIED THE DAY OF THE REPORT WHICH THE PATIENT 'DIDN'T FEEL GOOD AT' SO HIS HEALTHCARE PROVIDER PUT HIM BACK ON THE PREVIOUS SETTINGS. IT WAS NOTED THAT THE PAIN AND SPASMS WEREN'T RELATED TO ANY PARTICULAR ACTIVITY OR POSITION. THE REPORTER STATED THAT FILMS WERE DONE TO LOOK AT THE INTEGRITY OF THE WHOLE SYSTEM THE DAY PRIOR TO THE REPORT AND NO APPARENT FRACTURES WERE SEEN. IT WAS NOTED THAT THE PATIENT'S HEALTHCARE PROVIDER DIDN'T THINK THE EVENT WAS RELATED TO A NERVE. ADDITIONAL INFORMATION HAS BEEN REQUESTED BUT WAS NOT AVAILABLE AS OF THE DATE OF THIS REPORT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    175441 ACTIVA STIMULATOR, ELECTRICAL, IMPLANTED, FOR PARKINSONIAN TREMOR MRU MEDTRONIC MED REL MEDTRONIC PUERTO RICO 37601

    Patients

    Seq Age Sex Outcome Treatment
    1