BEUDAMED
    FDA Adverse Event Injury Summary report: N

    RESTORE ULTRA

    MDR report key: 3200941 · Received July 2, 2013

    Report

    Report Number
    3004209178-2013-11162
    Event Type
    Injury
    Date Received
    July 2, 2013
    Date of Event
    August 1, 2011
    Report Date
    April 14, 2026
    Manufacturer
    MEDTRONIC PUERTO RICO JUNCOS
    Product Code
    LGW
    UDI-DI
    00613994337672
    PMA / PMN Number
    P840001
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    H6 CODING UPDATED. MEDTRONIC SUBMITS THIS REPORT TO COMPLY WITH FDA REGULATIONS 21 CFR PARTS 4 AND 803. MEDTRONIC HAS MADE REASONABLE EFFORTS TO PROVIDE AS MUCH RELEVANT INFORMATION AS IS AVAILABLE TO THE COMPANY AS OF THE SUBMISSION DATE OF THIS REPORT. THIS REPORT DOES NOT CONSTITUTE AN ADMISSION OR A CONCLUSION BY FDA, MEDTRONIC, OR ITS EMPLOYEES THAT THE DEVICE, MEDTRONIC, OR ITS EMPLOYEE CAUSED OR CONTRIBUTED TO THE EVENT DESCRIBED IN THE REPORT. ANY REQUIRED FIELDS THAT ARE UNPOPULATED ARE BLANK BECAUSE THE INFORMATION IS CURRENTLY UNKNOWN OR UNAVAILABLE. MEDTRONIC WILL SUBMIT A SUPPLEMENTAL REPORT IF ADDITIONAL RELEVANT INFORMATION BECOMES KNOWN.

    Description of Event or Problem · 0

    NO NEW INFORMATION.

    Additional Manufacturer Narrative · 1

    (B)(4).

    Additional Manufacturer Narrative · 1

    PRODUCT ID 3778-60 LOT# SERIAL# (B)(4), IMPLANTED: 2011 (B)(6), PRODUCT TYPE LEAD PRODUCT ID 3778-60 LOT# SERIAL# (B)(4), IMPLANTED: 2011 (B)(6), PRODUCT TYPE LEAD PRODUCT ID 37752 LOT# SERIAL# (B)(4), PRODUCT TYPE RECHARGER PRODUCT ID 37743 LOT# SERIAL# (B)(4), PRODUCT TYPE PROGRAMMER, PATIENT. (B)(4).

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION RECEIVED REPORTED THAT IT WAS NOT DETERMINED HOW THE ELECTRODE BROKE. IT WAS STATED THAT WHEN THE LEAD WAS BEING REMOVED, THE PHYSICIAN NOTICED THE REMAINING ELECTRODE WAS DETACHED FROM THE LEAD AND IT DID NOT COME OUT WITH THE REST OF THE LEAD. THE ELECTRODE WAS BROKEN ON THE DISTAL END. THE BROKEN ELECTRODE WAS NOT REMOVED FROM THE PATIENT. IT WAS STATED THAT THE PATIENT STILL HAD THE ELECTRODE IN HER CERVICAL SPINE, BUT SHE WAS "DOING FINE".

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE LEAD WAS DAMAGED PRIOR TO A SURGICAL PROCEDURE. THE PATIENT HAD A DEVICE THAT WAS USED FOR CERVICAL PLACED LEADS. ONE ELECTRODE FROM ONE OF THE TWO LEADS REPORTEDLY WAS VISIBLY LOOSE/ SEPARATED FROM THE LEAD ON FLUOROSCOPY. IT WAS FURTHER REPORTED THAT WHEN THEY PULLED TO REMOVE THE LEAD THE ELECTRODE STAYED IN THE CERVICAL AREA. IT WAS NOTED THAT THE PATIENT HAD NOT BEEN ABLE TO USE THE LEADS IN THE CERVICAL AREA FOR THE YEAR PRIOR TO THE DATE OF THE REPORT AND THE DECISION WAS MADE TO REMOVE EVERYTHING IN THE CERVICAL REGION. ADDITIONAL INFORMATION HAS BEEN REQUESTED BUT WAS NOT AVAILABLE AS OF THE DATE OF THIS REPORT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    11747 RESTORE ULTRA STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF LGW MEDTRONIC PUERTO RICO JUNCOS 37712 00613994337672

    Patients

    Seq Age Sex Outcome Treatment
    1 24 YR Female Required Intervention