BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SURESCAN

    MDR report key: 6353133 · Received February 23, 2017

    Report

    Report Number
    3004209178-2017-04457
    Event Type
    Injury
    Date Received
    February 23, 2017
    Date of Event
    November 30, 2016
    Report Date
    November 1, 2018
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO.
    Product Code
    LGW
    UDI-DI
    00643169109513
    PMA / PMN Number
    P840001
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE MAIN COMPONENT OF THE SYSTEM AND OTHER APPLICABLE COMPONENTS ARE: PRODUCT TYPE: IMPLANTABLE NEUROSTIMULATOR. PRODUCT ID: 3778-45, SERIAL# (B)(4), IMPLANTED: (B)(6) 2010, PRODUCT TYPE: LEAD. PRODUCT ID: 3778-45, SERIAL# (B)(4), IMPLANTED: (B)(6) 2010, PRODUCT TYPE: LEAD.

    Additional Manufacturer Narrative · 1

    INFORMATION REFERENCES THE MAIN COMPONENT OF THE SYSTEM AND OTHER APPLICABLE COMPONENTS ARE: PRODUCT ID: 37702, SERIAL# (B)(4), IMPLANTED: (B)(6) 2010, EXPLANTED: (B)(6)2014, PRODUCT TYPE: IMPLANTABLE NEUROSTIMULATOR. PRODUCT ID: 3778-45, SERIAL# (B)(4), IMPLANTED: 2010, PRODUCT TYPE: LEAD. PRODUCT ID: 3778-45, SERIAL# (B)(4), IMPLANTED: (B)(6)2010, PRODUCT TYPE: LEAD. PRODUCT ID: NEU_UNKNOWN_LEAD, LOT# SERIAL# UNKNOWN, PRODUCT TYPE: LEAD. MEDTRONIC, INC. (MEDTRONIC) IS SUBMITTING THIS REPORT TO COMPLY WITH 21 C.F.R. PART 803, THE A GOOD FAITH EFFORT WILL BE MADE TO OBTAIN THE APPLICABLE INFORMATION RELEVANT TO THE REPORT. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Additional Manufacturer Narrative · 1

    IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Additional Manufacturer Narrative · 1

    IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Additional Manufacturer Narrative · 1

    CONTINUATION OF D11: PRODUCT ID 37702 LOT# SERIAL# (B)(4) IMPLANTED: 2010-(B)(6) EXPLANTED: 2014-(B)(6) PRODUCT TYPE IMPLANTABLE NEUROSTIMULATOR PRODUCT ID 3778-45 LOT# SERIAL# (B)(4) IMPLANTED: 2010-(B)(6) EXPLANTED: PRODUCT TYPE LEAD PRODUCT ID 3778-45 LOT# SERIAL# (B)(4) IMPLANTED: 2010-(B)(6) EXPLANTED: PRODUCT TYPE LEAD PRODUCT ID 3778-45 LOT# VA073LF017 SERIAL# IMPLANTED: EXPLANTED: PRODUCT TYPE LEAD PRODUCT ID 3778-45 LOT# VA13GJ9002 SERIAL# IMPLANTED: EXPLANTED: PRODUCT TYPE LEAD. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Additional Manufacturer Narrative · 1

    OTHER APPLICABLE COMPONENTS ARE: THE UNKNOWN LEAD HAS BEEN UPDATED TO PRODUCT ID 3778-45, LOT# VA073LF017. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Additional Manufacturer Narrative · 1

    INFORMATION REFERENCES THE MAIN COMPONENT OF THE SYSTEM AND OTHER APPLICABLE COMPONENTS ARE: PRODUCT ID 3778-45, SERIAL# (B)(4), IMPLANTED: (B)(6) 2010, PRODUCT TYPE: LEAD . PRODUCT ID: 3778-45, SERIAL# (B)(4), IMPLANTED: (B)(6) 2010, PRODUCT TYPE: LEAD. PRODUCT ID: NEU_UNKNOWN_LEAD, PRODUCT TYPE LEAD.

    Description of Event or Problem · 1

    INFORMATION WAS RECEIVED FROM A HEALTHCARE PROFESSIONAL OF A CLINICAL STUDY REGARDING A PATIENT WITH AN IMPLANTABLE NEUROSTIMULATOR (INS) FOR SPINAL PAIN AND FAILED BACK SURGERY SYNDROME. IT WAS REPORTED THE PATIENT COMPLAINED OF UNSATISFACTORY STIMULATION. THERE WERE COMPLAINTS OF THE STIMULATION NOT WORKING FOLLOWING A RECENT FALL. IMAGING PERFORMED ON (B)(6) 2016 DETERMINED THE LEAD MIGRATED. A DEVICE DIAGNOSIS OF LEAD MIGRATION/DISLODGEMENT AND CLINICAL DIAGNOSIS OF UNSATISFACTORY STIMULATION WAS REPORTED. THE LEAD WAS REPOSITIONED AND THE EVENT RESOLVED WITHOUT SEQUEALE.

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION RECEIVED FROM THE HEALTHCARE PROFESSIONAL OF THE CLINICAL STUDY REPORTED THAT THE LEAD WITH LOT NUMBER VA13GJ9002 WAS EXPLANTED.

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION FROM THE HEALTHCARE PROFESSIONAL OF THE CLINICAL STUDY REPORTED "DIFFICULT LEAD PLACEMENT DUE TO EPIDURAL FIBROSIS, LEAD PLACEMENT WAS IN SUBARACHNOID WHICH WAS ELECTED TO BE REMOVED".

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION WAS RECEIVED FROM A HEALTHCARE PROFESSIONAL (HCP) AND VIA A MANUFACTURER REPRESENTATIVE. IT WAS REPORTED THAT A LEAD REVISION OCCURRED ON (B)(6)-2018. THE OUTCOME OF THE EVENT WAS NOTED TO HAVE BEEN RESOLVED AS OF (B)(6)-2018. NO FURTHER COMPLICATIONS WERE REPORTED/ANTICIPATED.

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION RECEIVED FROM THE HEALTHCARE PROFESSIONAL OF THE CLINICAL STUDY REPORTED THAT, AT THE TIME OF THE LEAD REVISION ON (B)(6) 2016, ONE LEAD WAS EXPLANTED AND ATTEMPTED TO BE REPLACED WITH A NEW LEAD WHICH WAS UNSUCCESSFUL. THE PATIENT STILL HAS ONE LEAD IMPLANTED. THERE WAS NO FURTHER PATIENT COMPLICATION ASSOCIATED WITH THE EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    136986 SURESCAN STIMULATOR, SPINAL-CORD, IMPLANTED (PAIN RELIEF) LGW MEDTRONIC PUERTO RICO OPERATIONS CO. 97702 00643169109513

    Patients

    Seq Age Sex Outcome Treatment
    1 77 YR Required Intervention