BEUDAMED
    FDA Adverse Event Injury Summary report: N

    KINETRA

    MDR report key: 3314323 · Received August 28, 2013

    Report

    Report Number
    3004209178-2013-15354
    Event Type
    Injury
    Date Received
    August 28, 2013
    Report Date
    August 2, 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
    MN, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    CONCOMITANT MEDICAL PRODUCTS: PRODUCT ID 37602, SERIAL# (B)(4), IMPLANTED: (B)(6) 2012. PRODUCT TYPE: IMPLANTABLE NEUROSTIMULATOR: PRODUCT ID 37602, SERIAL# (B)(4), IMPLANTED: (B)(6) 2012. PRODUCT TYPE: IMPLANTABLE NEUROSTIMULATOR: PRODUCT ID 3387-40, LOT# J0427795V, IMPLANTED: (B)(6) 2004. PRODUCT TYPE: LEAD: PRODUCT ID 748266, SERIAL# (B)(4), IMPLANTED: (B)(6) 2004. PRODUCT TYPE: EXTENSION: PRODUCT ID 3550-09, LOT# N141423, IMPLANTED: (B)(6) 2009. PRODUCT TYPE: ACCESSORY: PRODUCT ID 3387-40, LOT# J0118386V, IMPLANTED: (B)(6) 2001. PRODUCT TYPE: LEAD: PRODUCT ID 7495-66, SERIAL# (B)(4), IMPLANTED: (B)(6) 2001. PRODUCT TYPE: EXTENSION: PRODUCT ID 7495-40, SERIAL# (B)(4), IMPLANTED: (B)(6) 2001. PRODUCT TYPE: EXTENSION: PRODUCT ID 7495-40, SERIAL# (B)(4), IMPLANTED: (B)(6) 2001. PRODUCT TYPE: EXTENSION: PRODUCT ID NEU_UNKNOWN_LEAD, SERIAL# UNKNOWN. PRODUCT TYPE: LEAD: PRODUCT ID NEU_UNKNOWN_LEAD, SERIAL# UNKNOWN. PRODUCT TYPE: LEAD: PRODUCT ID 3387-40, LOT# J0118386V, IMPLANTED: (B)(6) 2001. PRODUCT TYPE: LEAD: PRODUCT ID 3387-40, LOT# J0427795V, IMPLANTED: (B)(6) 2004. PRODUCT TYPE: LEAD: PRODUCT ID 7428, SERIAL# (B)(4). PRODUCT TYPE: IMPLANTABLE NEUROSTIMULATOR: PRODUCT ID NEU_UNKNOWN_EXT. PRODUCT TYPE: EXTENSION: PRODUCT ID NEU_UNKNOWN_EXT. PRODUCT TYPE: EXTENSION. (B)(4).

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT WAS HAVING AN IMPLANTABLE NEUROSTIMULATOR (INS) REPLACEMENT SURGERY WITH POSSIBLE REMOVAL OF EXTENSIONS. IT WAS NOTED THAT THE PATIENT HAD ¿MULTIPLE ISSUES¿ WITH THE INS¿S AND EXTENSIONS, AND POSSIBLY THE LEADS. IT WAS NOTED THAT THE SURGERY WAS SCHEDULED FOR (B)(6) 2013. IT WAS LATER REPORTED THE RIGHT LEAD IN THE INTERNAL GLOBUS PALLIDUS (GPI) WAS ¿OK,¿ BUT THE INS AND EXTENSION WERE REPLACED. IT WAS STATED THAT A CONTACT WAS >40,000 OHMS, SO THE EXTENSION WAS REPLACED. IT WAS NOTED ANOTHER CONTACT WAS HIGH WAS THAT IT WAS ¿EXPECTED.¿ ADDITIONAL INFORMATION WAS REQUESTED AND IF RECEIVED A SUPPLEMENTAL REPORT WILL BE SENT.

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION RECEIVED REPORTED THAT IT WAS UNKNOWN IF THAT PATIENT EXPERIENCED ANY SYMPTOMS RELATED TO THE SITUATION. IT WAS FURTHER NOTED THAT THE IT WAS UNKNOWN IF THE PATIENT WAS RECEIVING EFFECTIVE THERAPY AND THAT THE PATIENT OUTCOME WAS UNKNOWN. ADDITIONAL INFORMATION RECEIVED REPORTED THAT THE PATIENT WAS DOING WELL WITH THE LEADS PLACED IN THE GPI WHICH WERE CONNECTED TO THE RECHARGEABLE GENERATORS IN THE ABDOMEN. IT WAS NOTED THAT THE PHYSICIANS WERE STILL DECIDING WHETHER TO RE-IMPLANT THE PATIENT WITH NEW LEADS IN THE VIM THALAMUS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    424653 KINETRA IMPLANTED SUBCORTICAL ELECTRICAL STIMULATOR (MOTOR DISORDERS) MRU MEDTRONIC MED REL MEDTRONIC PUERTO RICO 7428

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention