BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ACTIVA

    MDR report key: 4093185 · Received September 16, 2014

    Report

    Report Number
    3004209178-2014-17103
    Event Type
    Injury
    Date Received
    September 16, 2014
    Report Date
    August 27, 2014
    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
    OH, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    CONCOMITANT MEDICAL PRODUCTS: PRODUCT ID: 3387S-40, LOT# V063294, IMPLANTED: (B)(6) 2007, PRODUCT TYPE: LEAD. PRODUCT ID: 7482A51, SERIAL# (B)(4), IMPLANTED: (B)(6) 2007, EXPLANTED: (B)(6) 2014, PRODUCT TYPE: EXTENSION. (B)(4).

    Additional Manufacturer Narrative · 1

    CONCOMITANT MEDICAL PRODUCTS: PRODUCT ID 37612, SERIAL# (B)(4), IMPLANTED: (B)(6) 2014, PRODUCT TYPE: IMPLANTABLE NEUROSTIMULATOR. PRODUCT ID 3708660, SERIAL# (B)(4), IMPLANTED: (B)(6) 2014, PRODUCT TYPE: EXTENSION. PRODUCT ID NEU_UNKNOWN_LEAD, IMPLANTED: (B)(6) 2014, PRODUCT TYPE: LEAD. PRODUCT ID 37612, SERIAL# (B)(4), IMPLANTED: (B)(6) 2014, PRODUCT TYPE: IMPLANTABLE NEUROSTIMULATOR. PRODUCT ID 3550-29, PRODUCT TYPE: ACCESSORY. PRODUCT ID 64001, LOT# N237219, IMPLANTED: (B)(6) 2011, EXPLANTED: (B)(6) 2014, PRODUCT TYPE: ADAPTER. PRODUCT ID 3387S-40, LOT# V063294, IMPLANTED: (B)(6) 2007, PRODUCT TYPE: LEAD. PRODUCT ID NEU_STIMLOC_ACC, PRODUCT TYPE: ACCESSORY. PRODUCT ID 3387S-40, LOT# V063294, IMPLANTED: (B)(6) 2007, PRODUCT TYPE: LEAD. PRODUCT ID 7482A51, SERIAL# (B)(4), IMPLANTED: (B)(6) 2007, EXPLANTED: (B)(6) 2014, PRODUCT TYPE: EXTENSION. ANALYSIS OF THE IMPLANTABLE NEUROSTIMULATOR FOUND NO SIGNIFICANT ANOMALIES, DEVICE WAS FUNCTIONALLY OK.

    Additional Manufacturer Narrative · 1

    CONCOMITANT PRODUCTS: PRODUCT ID 3550-29, PRODUCT TYPE ACCESSORY; PRODUCT ID 64001, LOT # N237219, PRODUCT TYPE ADAPTER; PRODUCT ID 3387S-40, LOT # V063294, IMPLANTED: (B)(6) 2007, PRODUCT TYPE LEAD; PRODUCT ID 3387S-40, LOT # V063294, IMPLANTED: (B)(6) 2007, PRODUCT TYPE LEAD; PRODUCT ID 7482A51, SERIAL # (B)(4), IMPLANTED: (B)(6) 2007, EXPLANTED: (B)(6) 2014, PRODUCT TYPE EXTENSION. ANALYSIS RESULTS WERE NOT AVAILABLE AT THE TIME OF THIS REPORT. A FOLLOW-UP REPORT WILL BE SENT WHEN ANALYSIS IS COMPLETE.

    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 THERE WAS A LOSS OF STIMULATION/THERAPEUTIC EFFECT AND A SHOCKING/JOLTING SENSATION. THE PATIENT HAD BEEN SHOCKED SEVERAL TIMES OVER THE PAST FEW WEEKS PRIOR TO THE DATE OF THIS REPORT AND THERAPY WAS LESS EFFECTIVE. THE PATIENT HAD EXPERIENCED PAIN ON THE RIGHT SIDE OF THE BODY. DIAGNOSTIC TESTING OR TROUBLESHOOTING HAD INCLUDED IMPEDANCE TESTING, X-RAYS AND REPROGRAMMING. IMPEDANCES HAD BEEN TAKEN WITH THE PATIENT IN DIFFERENT POSITIONS TO TRY TO RECREATE SHOCKING OR FIND ANY UNUSUAL IMPEDANCE. IMPEDANCE RESULTS WERE NORMAL AND HAD BEEN TESTED ON (B)(6) 2014. THE PRODUCT ISSUE WAS NOT RESOLVED AND THE CAUSE OF THE ISSUE WAS NOT DETERMINED. THE ACTION REQUIRED AS A RESULT OF THE EVENT WAS REPROGRAMMING AND THERE WAS AN ACTION THAT WAS PLANNED, BUT HAD NOT BEEN TAKEN YET WHICH WAS CONSIDERATION OF REPLACEMENT FOR THE DEVICE. THE PATIENT WAS ALIVE WITH NO INJURY. THE PATIENT WAS FINE WHEN SHE HAD LAST BEEN SEEN ON (B)(6) 2014 AND NO FURTHER REPORTS OF ANYTHING ELSE HAD BEEN RECEIVED. THE PATIENT WAS NOT RECEIVING EFFECTIVE THERAPY AND THERE WAS NO REASON TO SUSPECT THAT HAD CHANGED SINCE (B)(6) 2014. THE DEVICE WAS SCHEDULED TO BE SURGICALLY REPLACED ON (B)(6) 2014. THE DEVICE AND EXTENSION WERE REPLACED ON (B)(6) 2014 AND THEY WOULD TRY TO SEND THEM IN FOR ANALYSIS. THE LEAD HAD SHOWN IMPEDANCES HIGHER THAN NORMAL WITH 0 CONTACT GREATER THAN 40K, OTHER CONTACTS HAD IMPEDANCES BETWEEN 8 AND 10K. THE HEALTHCARE PROFESSIONAL BELIEVED THE LEAD MAY BE DAMAGED, WHICH COULD REQUIRE REPLACEMENT. THIS WAS GOING TO BE DISCUSSED WITH THE PATIENT. THE PATIENT WAS NOT RECEIVING EFFECTIVE THERAPY DUE THE PROBLEM WITH THE IMPEDANCES. NO PATIENT OUTCOME WAS PROVIDED. FURTHER FOLLOW-UP IS BEING CONDUCTED TO OBTAIN THIS INFORMATION. IF ADDITIONAL INFORMATION IS RECEIVED, A FOLLOW-UP REPORT WILL BE SUBMITTED.

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION RECEIVED REPORTED THAT THE DEVICES WERE SHIPPED ON (B)(6) 2014.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    573206 ACTIVA STIMULATOR, ELECTRICAL, IMPLANTED, FOR PARKINSONIAN TREMOR MHY MEDTRONIC MED REL MEDTRONIC PUERTO RICO 37612

    Patients

    Seq Age Sex Outcome Treatment
    1 00082 YR Required Intervention