BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SURESCAN

    MDR report key: 3900474 · Received June 27, 2014

    Report

    Report Number
    3004209178-2014-12210
    Event Type
    Injury
    Date Received
    June 27, 2014
    Date of Event
    March 20, 2014
    Report Date
    June 24, 2014
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO.
    Product Code
    LGW
    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

    PRODUCT ID 3487A-56, LOT# VA0BFSN, IMPLANTED: 2014 (B)(6); PRODUCT TYPE LEAD PRODUCT ID 3487A-56, LOT# VA0BFSN, IMPLANTED: 2014 (B)(6); PRODUCT TYPE LEAD PRODUCT ID 3487A-56, LOT# VA0AZCL, IMPLANTED: 2014 (B)(6); PRODUCT TYPE LEAD PRODUCT ID 3487A-56, LOT# VA0AZCL, IMPLANTED: 2014 (B)(6); PRODUCT TYPE LEAD PRODUCT ID 3708240, SERIAL# (B)(4), IMPLANTED: 2014 (B)(6); PRODUCT TYPE EXTENSION PRODUCT ID 3708240, SERIAL# (B)(4), IMPLANTED: 2014 (B)(6); PRODUCT TYPE EXTENSION PRODUCT ID 97754, SERIAL# (B)(4); PRODUCT TYPE RECHARGER PRODUCT ID 97740, SERIAL# (B)(4); PRODUCT TYPE PROGRAMMER, PATIENT. (B)(4).

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION RECEIVED REPORTED THAT THE EVENT WAS RELATED TO LEAD 2.

    Description of Event or Problem · 1

    IT WAS REPORTED, THE PATIENT HAD ADVERSE STIMULATION. THE PATIENT HAD STIMULATION COVERAGE TO THEIR LEG THAT EXACERBATED THEIR KNEE PAIN. DEVICE INTERROGATION AND DEVICE DATA WAS NORMAL. THE EVENT WAS NOTED AS RELATED TO THE PROGRAMMING/STIMULATION. THE PATIENT WAS REPROGRAMMED AND THE EVENT RESOLVED WITHOUT SEQUELAE. IT WAS REPORTED THE PATIENT HAD ADVERSE STIMULATION. THE PATIENT HAD WORSENING OF BILATERAL ANTERIOR KNEE BURNING PAIN WITH USE OF STIMULATION. DEVICE INTERROGATION WAS NORMAL. THE EVENT WAS NOTED AS ONGOING. IT WAS REPORTED, THE PATIENT HAD ADVERSE STIMULATION PARESTHESIA. THE PATIENT HAD DIFFUSE LEG PAIN AND INTERVENTION WAS NOTED AS REPROGRAMMING. THE EVENT WAS NOTED AS ONGOING AND NOT RELATED TO THE DEVICE BUT RELATED TO THE PROGRAMMING. ADDITIONAL INFORMATION REPORTED THE EVENT WAS RESOLVED WITHOUT SEQUELAE. IT WAS REPORTED, THE PATIENT HAD ADVERSE STIMULATION PARESTHESIA. THE PATIENT HAD BILATERAL LEG PAIN WHEN USING THE STIMULATOR. DEVICE INTERROGATION SHOWED NORMAL. THE EVENT WAS NOTED AS RELATED TO PROGRAMMING. THE DEVICE WAS REPROGRAMMED AND THE EVENT WAS CONSIDERED RESOLVED WITHOUT SEQUELAE. IT WAS REPORTED THAT THE PATIENT EXPERIENCED ADVERSE STIMULATION. IT WAS NOTED THAT THERE WAS WORSENING OF THE BILATERAL ANTERIOR KNEE BURNING PAIN WITH USE OF NEUROSTIMULATION. IT WAS NOTED THAT THE DEVICE WAS INTERROGATED AND DEVICE DATA WAS NORMAL FOR THE PATIENT ON 2014 (B)(6). IT WAS NOTED THAT THE LEAD WAS REPOSITIONED. IT WAS NOTED THAT THE LEAD WAS ADVANCED 5 MM IN A CEPHALAD DIRECTION ON 2014 (B)(6). IT WAS NOTED THAT THE DEVICE WAS REPROGRAMMED ON 2014 (B)(6). IT WAS NOTED THAT THE EVENT WAS ONGOING. ADDITIONAL INFORMATION RECEIVED REPORTED THAT ONE OF THE LEADS WAS EXPLANTED AND REPLACED.

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION RECEIVED REPORTED THAT THE PATIENT WAS REPROGRAMMED ON (B)(6) 2014. IT WAS NOTED THAT THE EVENT WAS ONGOING. ADDITIONAL INFORMATION RECEIVED REPORTED THAT THE PATIENT WAS REPROGRAMMED ON (B)(6) 2014. IT WAS NOTED THAT THE EVENT WAS ONGOING. ADDITIONAL INFORMATION RECEIVED REPORTED THAT THE PATIENT WAS REPROGRAMMED ON (B)(6) 2014. IT WAS NOTED THAT THE EVENT WAS ONGOING. ADDITIONAL INFORMATION RECEIVED REPORTED THAT THE EVENT RESOLVED WITHOUT SEQUELAE ON (B)(6) 2014.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    377049 SURESCAN STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF LGW MEDTRONIC PUERTO RICO OPERATIONS CO. 97714

    Patients

    Seq Age Sex Outcome Treatment
    1 00070 YR Required Intervention