BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ACTIVA

    MDR report key: 3110073 · Received May 13, 2013

    Report

    Report Number
    3004209178-2013-07601
    Event Type
    Injury
    Date Received
    May 13, 2013
    Date of Event
    April 24, 2013
    Report Date
    April 24, 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
    CO, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    CONCOMITANT PRODUCT: PRODUCT ID 64002, SERIAL# UNKNOWN, IMPLANTED: (B)(6) 2011, PRODUCT TYPE ADAPTER. ANALYSIS RESULTS WERE NOT AVAILABLE AT THE TIME OF THIS REPORT. A FOLLOW-UP REPORT WILL BE SENT WHEN ANALYSIS IS COMPLETED.

    Additional Manufacturer Narrative · 1

    CONCOMITANT MEDICAL PRODUCTS: PRODUCT ID 3387-40, LOT# V000392, IMPLANTED: (B)(6) 2006. PRODUCT TYPE: LEAD: PRODUCT ID 3387-40, LOT# V000392, IMPLANTED: (B)(6) 2006. PRODUCT TYPE: LEAD: PRODUCT ID 748251, SERIAL# (B)(4), IMPLANTED: (B)(6) 2007. PRODUCT TYPE: EXTENSION: PRODUCT ID 7482A51, SERIAL# (B)(4), IMPLANTED: (B)(6) 2007. PRODUCT TYPE: EXTENSION: PRODUCT ID NEU_PTM_PROG. PRODUCT TYPE: PROGRAMMER, PATIENT. (B)(4).

    Additional Manufacturer Narrative · 1

    (B)(4).

    Additional Manufacturer Narrative · 1

    ANALYSIS OF THE ADAPTOR REVEALED NO ANOMALIES.

    Additional Manufacturer Narrative · 1

    IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT EXPERIENCED AN ERROR CODE ON THE PATIENT PROGRAMMER. THE PATIENT COULD NOT SEE THE CODE WELL AND IT WAS THOUGHT IT WAS EITHER AN OUT OF REGULATION (OOR) OR 006 CODE. ADDITIONAL INFORMATION WAS RECEIVED THAT REPORTED THE PATIENT WAS UNABLE TO ADJUST STIMULATION. THE PATIENT PROGRAMMER SHOWED AN OOR CONDITION. IT WAS NOTED THAT THE PATIENT NOTICED THE OOR MESSAGE DURING A NORMAL CHECK ON THE PRIOR DAY. THE PATIENT WAS NOT MAKING ANY ADJUSTMENTS AT THE TIME OF THE OOR. THE PHYSICIAN PROGRAMMER SHOWED THE MESSAGE "PATIENT WILL RECEIVE A LOWER DELIVERED STIMULATION THAN EXPECTED." IMPEDANCES WERE MEASURED AND FOUND TO BE WITHIN NORMAL RANGES. NO CHANGES IN IMPEDANCES WERE SEEN WHEN THE PATIENT WAS IN DIFFERENT POSITIONS. THE PATIENT'S WIFE STATED THAT SHE DID NOT BELIEVE THE PATIENT LOST THERAPY, BUT THE PATIENT STATED THAT HE THOUGHT HE DID LOSE THERAPEUTIC BENEFIT. ADJUSTING THE STIMULATION AMPLITUDE DID NOT RESULT IN AN OOR. THE PATIENT WAS GOING TO CONTACT THE PHYSICIAN IF THE ISSUE OCCURRED AGAIN. THE COMPANY REPRESENTATIVE REPORTED THE FOLLOWING DAY THAT THE PATIENT DID NOT HAVE A SIGNIFICANT CHANGE IN SYMPTOMS. THE OOR COULD NOT BE REPLICATED FOLLOWING AN IMPEDANCE CHECK AND THE PATIENT WAS INSTRUCTED TO CONTACT THE REPRESENTATIVE IF THE OOR OCCURRED AGAIN. APPROXIMATELY ONE WEEK LATER, IT WAS REPORTED THAT THE PATIENT WAS UNABLE TO ADJUST STIMULATION AND RECEIVED ANOTHER OOR MESSAGE. THE PATIENT WAS ADJUSTING STIMULATION ON BOTH SIDES OF THE BODY THE PREVIOUS NIGHT WHEN THE OOR OCCURRED. THE PATIENT WAS UNABLE TO BYPASS THE OOR. ADDITIONAL INFORMATION WAS REQUESTED BUT WAS NOT AVAILABLE AT THE TIME OF THIS REPORT.

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION STATED A ¿CALL YOUR DOCTOR ICON¿ AND OOR CONDITION WERE OBSERVED. IT WAS NOTED THAT STIMULATION WAS UNABLE TO BE ADJUSTED. THE PATIENT WAS SEEN BY THEIR HEALTH CARE PROVIDER (HCP) ON (B)(6) 2013. IT WAS NOTED THE PATIENT HAD EXPERIENCED ¿SIX WEEKS OF GETTING OOR WITH VOLTAGE INCREASE¿ PRIOR TO MEETING WITH THEIR HCP. IT WAS FURTHER NOTED THE PATIENT EXPERIENCED A ¿LOSS OF THERAPY¿ AND A RETURN OF TREMORS FOR THE TEN DAYS PRIOR TO MEETING WITH THEIR HCP. THE PATIENT REPORTED ¿HE FELT SOME PRESSURE ON THE RIGHT SIDE OF HIS HEAD PRIOR TO THE OOR¿ CONDITION. IT WAS NOTED THE PRESSURE CONDITION DID NOT OCCUR AGAIN. IT WAS FURTHER REPORTED THE PATIENT¿S OOR CONDITION WAS REPEATABLE IN THE CLINIC BY ¿INCREASING THE VOLTAGE.¿ WHEN THE VOLTAGE WAS REDUCED, THE ¿OOR CONDITION WENT AWAY.¿ IMPEDANCE TESTING REVEALED ¿NO APPARENT SHORT CIRCUITS.¿ IT WAS STATED THAT PALPATION OF THE PATIENTS IMPLANTABLE NEUROSTIMULATOR (INS) SITE ELICITED HIGH IMPEDANCES IN THE RANGE OF 13,736-14,232 OHMS ON CONTACT ONE. IT WAS NOTED THESE HIGH IMPEDANCES COULD NOT BE REPEATED AND THE PATIENT¿S INS DID NOT EXHIBIT THE OOR OR ABNORMAL IMPEDANCES WITH POSITIONAL CHANGES. IT WAS NOTED THAT CONTACT ONE WAS ¿REPROGRAMMED AROUND¿ AND THAT FOLLOWING THIS THE PATIENT ¿NO LONGER HAD THE OOR CONDITION.¿ THE PATIENT¿S RIGHT SIDE OF THERAPY HAD IMPEDANCES IN THE RANGE OF 1100-1900 OHMS AND EXHIBITED ¿NO PROBLEMS.¿

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    210496 ACTIVA STIMULATOR, ELECTRICAL, IMPLANTED, FOR PARKINSONIAN TREMOR MHY MEDTRONIC MED REL MEDTRONIC PUERTO RICO 37601

    Patients

    Seq Age Sex Outcome Treatment
    1 00064 YR Required Intervention