BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ACTIVA

    MDR report key: 3863925 · Received June 10, 2014

    Report

    Report Number
    3004209178-2014-11279
    Event Type
    Injury
    Date Received
    June 10, 2014
    Report Date
    May 22, 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
    WV, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    CONCOMITANT MEDICAL PRODUCTS: PRODUCT ID 3387S-40, LOT# VA0FGE1, PRODUCT TYPE: LEAD; PRODUCT ID 3389S-40, LOT# V 323744, PRODUCT TYPE: LEAD; PRODUCT ID 7482A95, SERIAL# (B)(4), PRODUCT TYPE: EXTENSION; PRODUCT ID 7482A95, SERIAL# (B)(4), PRODUCT TYPE: EXTENSION.

    Additional Manufacturer Narrative · 1

    CONCOMITANT MEDICAL PRODUCTS: PRODUCT ID 3387S-40, LOT# VA0FGE1, PRODUCT TYPE: LEAD. PRODUCT ID 3389S-40, LOT# V 323744, PRODUCT TYPE: LEAD. PRODUCT ID 7482A95, SERIAL# (B)(4), PRODUCT TYPE: EXTENSION. PRODUCT ID 7482A95, SERIAL# (B)(4), PRODUCT TYPE: EXTENSION. (B)(4).

    Additional Manufacturer Narrative · 1

    (B)(4).

    Additional Manufacturer Narrative · 1

    CONCOMITANT MEDICAL PRODUCTS: PRODUCT ID: 3387S-40, LOT# VA0FGE1, PRODUCT TYPE: LEAD. PRODUCT ID: 3389S-40, LOT# V323744, PRODUCT TYPE: LEAD. PRODUCT ID: 7482A95, SERIAL# (B)(4), PRODUCT TYPE: EXTENSION. PRODUCT ID: 7482A95, SERIAL# (B)(4), PRODUCT TYPE: EXTENSION. (B)(4).

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION RECEIVED REPORTED THAT THE SURGERY WAS PERFORMED ON THE PREVIOUSLY NOTED DATE. THE REPORTER HAD NO FURTHER INFORMATION TO GIVE AS A DIFFERENT REPRESENTATIVE COVERED THE CASE. ADDITIONAL INFORMATION WAS REQUESTED FROM THE REPRESENTATIVE WHO COVERED THE CASE AND IF ADDITIONAL INFORMATION IS RECEIVED A SUPPLEMENTAL REPORT WILL BE SENT.

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION RECEIVED REPORTED THEY WERE STILL WORKING ON THE PATIENT. ALL ASSOCIATED DEVICES WOULD BE SENT BACK ONCE ALL OF THE PATIENT¿S PROCEDURES WERE FINISHED. THURSDAY (B)(6) 2014 THE STIMULATOR AND ADAPTOR WERE REPLACED.

    Description of Event or Problem · 1

    IT WAS LATER REPORTED THAT 1-2 WEEKS POST REPLACEMENT THE IMPEDANCES GOT WORSE AGAIN AND THE SHOCKING. IT WAS NOTED THAT THE PATIENT WENT BACK TO SURGERY AND HAD THE IMPLANTABLE NEUROSTIMULATOR (INS) REPLACED. NO FLUID WAS SEEN AT THE CONNECTOR BLOCK AND THERE WERE NO ISSUES WITH THE INS WHEN DISCONNECTING. THE PLUG AND ADAPTOR WERE REPLACED ALSO.

    Description of Event or Problem · 1

    IT WAS FURTHER REPORTED THE PATIENT HAD AN APPOINTMENT SCHEDULED FOR AN X-RAY AND APPOINTMENT WITH THEIR HEALTH CARE PROFESSIONAL ON (B)(6) 2014.

    Description of Event or Problem · 1

    INFORMATION WAS PREVIOUSLY REPORTED IN MANUFACTURERS REPORT NUMBER 3004209178-2014-11828, ANY ADDITIONAL INFORMATION RECEIVED WILL BE REPORTED UNDER THIS MANUFACTURERS REPORT NUMBER.

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION RECEIVED THE LEAD WAS REPLACED THE DAY THAT THE MANUFACTURER REPRESENTATIVE WAS THERE AND THE IMPEDANCES WERE WITHIN NORMAL RANGE AND NO PROBLEMS WERE FOUND.

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION RECEIVED REPORTED THE PATIENT'S LEAD WAS INTERROGATED ON (B)(6) 2014 AND THEY WERE SCHEDULED FOR A REPLACEMENT SURGERY ON (B)(6) 2014.

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION RECEIVED REPORTED THAT THE PATIENT WAS GETTING AN X-RAY OF THE LEAD CONNECTOR AND COMING TO CLINIC THE FRIDAY AFTER THE REPORT.

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION RECEIVED REPORTED THAT AN ENGINEER HELPED THE REPORTER "ON FRIDAY" TO PROGRAM AROUND THE RIGHT LEAD AND ISOLATE THE PROBLEM TO THE LEFT LEAD. THE PATIENT WOULD BE SCHEDULED SHORTLY FOR A REPLACEMENT.

    Description of Event or Problem · 1

    IT WAS REPORTED EARLIER IN THE WEEK PRIOR TO REPORT, POST-IMPLANT, THE PATIENT EXPERIENCED SHOCKING AND THEN HAD A LOSS OF SYMPTOM RELIEF ON ONE SIDE AND THEN SUBSEQUENTLY THE OTHER SIDE. IT WAS STATED THE DOCTOR WOULD LIKELY RE-IMPLANT IN A DIFFERENT LOCATION WITH A DIFFERENT ADAPTOR AND DIFFERENT PLUGS AND A NEW IMPLANTABLE NEUROSTIMULATOR (INS).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    340872 ACTIVA STIMULATOR, ELECTRICAL, IMPLANTED, FOR PARKINSONIAN TREMOR MHY MEDTRONIC MED REL MEDTRONIC PUERTO RICO 37601

    Patients

    Seq Age Sex Outcome Treatment
    1 00065 YR Required Intervention