BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ACTIVA

    MDR report key: 3314378 · Received August 28, 2013

    Report

    Report Number
    3004209178-2013-15359
    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
    GA, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    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, SERIAL# (B)(4), IMPLANTED: 2001 (B)(6); PRODUCT TYPE EXTENSION PRODUCT ID NEU_UNKNOWN_LEAD,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 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).

    Additional Manufacturer Narrative · 1

    (B)(4).

    Additional Manufacturer Narrative · 1

    (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 NOTED THAT THE PATIENT HAD ¿MULTIPLE ISSUES¿ WITH THE INS AND EXTENSION, AND POSSIBLY THE LEAD. IT WAS NOTED THAT THE SURGERY WAS SCHEDULED FOR (B)(6) 2013. SIX DAYS AFTER INITIAL REPORT, IT WAS REPORTED THAT THE LEAD IN THE VENTRAL INTERMEDIATE (VIM) WAS NOT CONNECTED TO THE EXTENSION AND THE IMPEDANCES WERE NOT READING HIGH AS EXPECTED. IT WAS NOTED THE VALUES WERE BETWEEN 1000-10,000 OHMS. PRIOR TO SURGERY THE IMPEDANCES WERE FINE. IT WAS NOTED THAT A PORT WAS SUTURED TO ¿WICK¿ OUT ANY FLUID BUT IT WAS DRY. IT WAS LATER REPORTED THAT THE LEAD IN THE VIM WAS THE ISSUE AS IT WAS "BAD." IT WAS NOTED THAT THE LEAD WAS ¿STRIPPED, FRAYED, CONTACTS PUSHED TOGETHER AND STRIPPED.¿ THE LEAD WAS TO BE REPLACED. REFERENCE MANUFACTURING REPORT #3004209178-2013-15354, #3004209178-2013-15355, AND #3004209178-2013-15358. ADDITIONAL INFORMATION WAS REQUESTED AND A SUPPLEMENTAL REPORT WILL BE SENT IF RECEIVED.

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION RECEIVED REPORTED THAT THERE WAS A REPLACEMENT DUE TO HIGH IMPEDANCES. IT WAS NOTED THAT DIAGNOSTIC TESTING OR TROUBLESHOOTING WAS PERFORMED BUT IT WAS UNKNOWN WHAT WAS DONE. IT WAS NOTED THAT THE PRODUCT ISSUE WAS RESOLVED. IT WAS NOTED THAT THE CAUSE OF THE ISSUE WAS NOT DETERMINED. IT WAS NOTED THAT THE RIGHT EXTENSION WAS REPLACED AS WELL DUE TO HIGH IMPEDANCES OR OPEN CIRCUIT. IT WAS NOTED THAT IT WAS NO POSSIBLE TO DETERMINE WHICH OF THE EXTENSIONS WERE EXPLANTED. IT WAS FURTHER NOTED THAT THE LEAD ON THE LEFT SIDE WAS REMOVED DUE TO HIGH IMPEDANCES AS WELL. IT WAS NOTED THAT SIGNS AND SYMPTOMS OF THE EVENT INCLUDED LESS THAN 50 PERCENT THERAPY RELIEF. IT WAS NOTED THAT THE LOCATION OF THE ISSUE OR SYMPTOM WAS THE EXTENSION AND LEAD LOCATION. IT WAS NOTED THAT THE LEFT AND RIGHT VIM LEADS WERE REPLACED DUE TO OPEN CIRCUIT AND LACK OF EFFICACY. IT WAS NOTED THAT THE RIGHT EXTENSION WAS REPLACED DUE TO OPEN CIRCUIT. IT WAS NOTED THAT AFTER THE REVISION THE PATIENT'S RIGHT AND LEFT VIM LEADS AND EXTENSIONS HAVE NORMAL IMPEDANCES. IT WAS NOTED THAT THE VIM LEADS WOULD BE PROGRAMMED IN 2-3 WEEKS. IT WAS NOTED THAT THE PATIENT'S STATUS AT THE TIME OF REPORT WAS ALIVE WITH NO INJURY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    423933 ACTIVA IMPLANTED SUBCORTICAL ELECTRICAL STIMULATOR (MOTOR DISORDERS) MRU MEDTRONIC MED REL MEDTRONIC PUERTO RICO 37602

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention