BEUDAMED
    FDA Adverse Event Injury Summary report: N

    KINETRA

    MDR report key: 3314338 · Received August 28, 2013

    Report

    Report Number
    3004209178-2013-15355
    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

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

    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.

    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 AND EXTENSION, AND POSSIBLY THE LEADS. IT WAS NOTED THAT THE SURGERY WAS SCHEDULED FOR (B)(6) 2013. IT WAS LATER REPORTED THAT THE LEAD IN THE INTERNAL GLOBUS PALLIDUS (GPI) WAS ¿OK,¿ BUT THE INS AND EXTENSION WERE REPLACED. IMPEDANCES HAD ¿???¿ READINGS AND IMPEDANCES AS LOW AS 94 OHMS. AS A RESULT, EXTENSION AND INS WERE REPLACED. REFERENCE MANUFACTURING REPORT #3004209178-2013-15354. ADDITIONAL INFORMATION WAS REQUESTED AND A SUPPLEMENTAL REPORT WILL BE SENT IF RECEIVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    424714 KINETRA IMPLANTED SUBCORTICAL ELECTRICAL STIMULATOR (MOTOR DISORDERS) MRU MEDTRONIC MED REL MEDTRONIC PUERTO RICO 7428

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention