BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACTIVA

    MDR report key: 2713203 · Received August 24, 2012

    Report

    Report Number
    3004209178-2012-07308
    Event Type
    Malfunction
    Date Received
    August 24, 2012
    Report Date
    July 26, 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
    CA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Additional Manufacturer Narrative · 1

    PRODUCT ID: 7482A51, SERIAL#: (B)(4), IMPLANTED: (B)(6) 2009, PRODUCT TYPE: EXTENSION; PRODUCT ID: 7482A51, SERIAL#: (B)(4), PRODUCT TYPE: EXTENSION; PRODUCT ID: 3387S-40, LOT#: V192123, IMPLANTED: (B)(6) 2009, PRODUCT TYPE: LEAD; PRODUCT ID: 3387S-40, LOT#: V192123, PRODUCT TYPE: LEAD. (B)(4).

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION INDICATED THAT THE INFORMATION REPORTED IN MFR. REPORT # 3007566237-2013-01736 PERTAINED TO THIS EVENT. ADDITIONAL INFORMATION INDICATED THAT THE HIGH IMPEDANCES PERTAINED TO THE PATIENT¿S OTHER DEVICE AS REPORTED IN MFR. REPORT # 3004209178-2012-07307 AND NOT TO THIS DEVICE. IT WAS NOTED THAT THE PATIENT HAD NOT HAD ANY ISSUES WITH THERAPY SINCE THE HIGH IMPEDANCE ON THE PATIENT¿S OTHER DEVICE RESOLVED.

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION WAS RECEIVED. IT WAS REPORTED THAT THE IMPEDANCES WERE LIKELY DUE TO AN ARTIFACT AND WERE A TRANSIENT PROBLEM. THE IMPEDANCES WERE NORMAL NOW AND NO ERROR MESSAGES WERE SEEN, HOWEVER, THE PATIENT HAD BEEN REPROGRAMMED ELSEWHERE. IMAGING WAS PERFORMED AND THE RESULTS WERE "NORMAL," THOUGH IT WAS UNKNOWN WHETHER THE SCAN WAS AN MRI, CT, OR X-RAY. IT WAS REPORTED THAT THERE WAS NO SURGICAL INTERVENTION OR HOSPITALIZATION AND THE PATIENT OUTCOME WAS REPORTED AS "NO INJURY." REFER TO MANUFACTURER REPORT #3004209178-2012-07307. THE PATIENT HAD TWO IMPLANTABLE STIMULATORS AND IT WAS UNCLEAR WHICH DEVICE WAS RELATED TO THIS EVENT.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT EXPERIENCED A LOSS OF THERAPEUTIC EFFECT FOLLOWING A DEVICE REPLACEMENT SURGERY AND NEEDED CRUTCHES TO MOVE AROUND; FOLLOWING THE PROCEDURE, THE PATIENT WAS PROGRAMMED TO A STIMULATION AMPLITUDE OF 3.5 VOLTS, A PULSE WIDTH OF 210 MICROSECONDS, A RATE OF 75 HZ, AND AN ELECTRODE CONFIGURATION OF C+, 2-, 3-. THE PATIENT SAW HIS PHYSICIAN IN (B)(6) 2012 FOR A FOLLOW-UP APPOINTMENT AND IT WAS NOTED THAT ELECTRODE #2 HAD AN IMPEDANCE VALUE GREATER THAN 40,000 OHMS; IT WAS NOTED THAT THE CONTACT HAD ALWAYS BEEN SUCCESSFUL IN THE PAST AND USED IN PROGRAMMING OF THE DEVICE. THE PATIENT VISITED HIS PHYSICIAN AGAIN IN (B)(6)2012 FOR A REPLACEMENT PROCEDURE, BUT IT WAS CANCELLED WHEN HIS PHYSICIAN INTERROGATED THE DEVICE AND FOUND THAT THE HIGH IMPEDANCE VALUE WAS NORMAL AND NOT SHOWING AN OPEN CIRCUIT; THE PHYSICIAN CONCLUDED THAT THEY COULDN'T SEE ANY ISSUE WITH THE SYSTEM. THE PATIENT WAS GIVEN 4 DIFFERENT PROGRAMS BY HIS PHYSICIAN WHO USED THE CONFIGURATION C+, 2-, 3- ON ALL GROUPS. THE PATIENT WAS GIVEN THE ABILITY TO ADJUST AMPLITUDE, RATE, AND PULSE WIDTH. THE PATIENT WAS ON A PROGRAM OF A STIMULATION AMPLITUDE OF 3.5 VOLTS, A PULSE WIDTH OF 60 MICROSECONDS, A RATE OF 130 HZ, AND A PROGRAM OF A STIMULATION AMPLITUDE OF 5.0 VOLTS, A PULSE WIDTH OF 60 MICROSECONDS, A RATE OF 75 HZ. THE PATIENT HAD TO BE ON A PROGRAM FOR 3 WEEKS AT A TIME BECAUSE IT WAS HOW LONG IT TOOK TO SEE ANY BENEFIT OR CHANGES. THE PATIENT WAS GOING BACK TO ORIGINAL SETTINGS OF A STIMULATION AMPLITUDE OF 3.5 VOLTS, A PULSE WIDTH OF 210 MICROSECONDS, A RATE OF 75 HZ, AND AN ELECTRODE CONFIGURATION OF C+, 2-, 3-. IT WAS NOTED THAT THE AFFECTED AREA WAS THE RIGHT LEG. THE PATIENT'S STATUS WAS FAIR. THE PATIENT WANTED TO GET BACK TO HOW HE WAS THE PREVIOUS (B)(6) (2011) WHERE HE WAS ABLE TO WALK WITHOUT CRUTCHES AND ONLY USE A CANE FOR ASSISTANCE IF NEEDED. HE WANTED TO DO THINGS WITH HIS WIFE AGAIN. IT WAS PLANNED THAT THE PATIENT WAS TO MEET WITH A NEW PHYSICIAN FOR CONSULTATION AS HIS CURRENT LOCATION HAD CHANGED. IT WAS NOTED THAT THE PATIENT HAD A DUAL STIMULATION SYSTEM IMPLANTED AND THE RELEVANT DEVICE OR DEVICES WAS NOT SPECIFIED; RELATED DEVICE HAD MODEL#: 37602 AND SERIAL#: (B)(4). ADDITIONAL INFORMATION HAS BEEN REQUESTED, BUT WAS NOT AVAILABLE AS OF THE DATE OF THIS REPORT. REFER TO MANUFACTURER'S REPORT # 3004209178-2012-07307.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ACTIVA STIMULATOR, ELECTRICAL, IMPLANTED, FOR PARKINSONIAN TREMOR MHY MEDTRONIC MED REL MEDTRONIC PUERTO RICO 37602

    Patients

    Seq Age Sex Outcome Treatment
    1