BEUDAMED
    FDA Adverse Event Injury Summary report: N

    RESTORE ULTRA

    MDR report key: 3981750 · Received August 5, 2014

    Report

    Report Number
    3004209178-2014-13987
    Event Type
    Injury
    Date Received
    August 5, 2014
    Report Date
    July 14, 2014
    Manufacturer
    MEDTRONIC MED REL MEDTRONIC PUERTO RICO
    Product Code
    LGW
    PMA / PMN Number
    P840001
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4)

    Additional Manufacturer Narrative · 1

    CONCOMITANT MEDICAL PRODUCTS: PRODUCT ID 39565-30, SERIAL# (B)(4), EXPLANTED: (B)(6) 2014, PRODUCT TYPE: LEAD. (B)(4).

    Additional Manufacturer Narrative · 1

    CONCOMITANT PRODUCTS: PRODUCT ID 39565-30, SERIAL # (B)(4), IMPLANTED: (B)(6) 2011, PRODUCT TYPE LEAD; PRODUCT ID 3708120, SERIAL # (B)(4), IMPLANTED: (B)(6) 2011, PRODUCT TYPE EXTENSION; PRODUCT ID 37743, SERIAL # (B)(4), PRODUCT TYPE PROGRAMMER, PATIENT; PRODUCT ID 37752, SERIAL # (B)(4), PRODUCT TYPE RECHARGER; PRODUCT ID 3708120, SERIAL # (B)(4), IMPLANTED: (B)(6) 2011, PRODUCT TYPE EXTENSION; PRODUCT ID 39565-30, SERIAL # (B)(4), IMPLANTED: (B)(6) 2011, PRODUCT TYPE LEAD. (B)(4).

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION RECEIVED REPORTED THAT THE LEAD REPLACEMENT WAS SCHEDULED FOR (B)(6). NO OUTCOME WAS REPORTED REGARDING THIS EVENT. FURTHER FOLLOW-UP IS BEING CONDUCTED. IF ADDITIONAL INFORMATION IS RECEIVED, A FOLLOW-UP REPORT WILL BE SENT.

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION RECEIVED REPORTED THAT THE CAUSE OF ISSUE WAS DETERMINED. THIS WAS DESCRIBED AS READINGS FROM THE BATTERY GENERATOR REVEALED THAT THERE WAS A "CRACK IN THE SYSTEM" AND HE WAS HAVING A SHORT SOMEWHERE. SURGERY WAS DONE (B)(6) 2014 TO REMOVE THE NONFUNCTIONAL PADDLE LEAD. THERE WAS A LAMINOTOMY WITH REPLACEMENT NEW LEAD. THE PATIENT OUTCOME WAS NOT RECOVERED WITH SYMPTOMS/ISSUE ONGOING. THE PATIENT WAS STILL RECOVERING AND WOULD RETURN FOR FOLLOW-UP (B)(6) 2014. THE ISSUE WAS DEVICE RELATED.

    Description of Event or Problem · 1

    IT WAS REPORTED THE PATIENT WAS IN FOR A PUMP REFILL AND NOTIFIED THE NURSE THAT THE STIMULATOR NEEDED TO BE ADJUSTED. IT WAS NOTED THAT THEY WERE ABLE TO REPROGRAM FOR LEGS AND RIGHT BACK BUT WAS UNABLE TO CAPTURE LEFT BACK TO DUE IMPEDANCES OUT OF RANGE. IT THAT NOTED THERE WERE FOUR CONTACTS ¿OUT¿ ON THE LEAD. IT WAS ALSO NOTED THAT THERE WAS >10,000 IMPEDANCE ON FOUR CONTACTS. THE CONTACTS LISTED WERE 9, 10, 13 AND 14. SYMPTOMS OR COMPLICATIONS ASSOCIATED WITH THE EVENT INCLUDED LESS THAN 50% THERAPY RELIEF IN THE LEFT BACK. IT WAS NOTED THAT STIMULATION/THERAPY ISSUES WERE DESCRIBED AS STIMULATION IN THE WRONG LOCATION. IT WAS NOTED THAT THERE WAS A LEAD REPLACEMENT PLANNED WITH THE DOCTOR. IT WAS ALSO NOTED THAT THE PATIENT WAS SCHEDULED WITH THE DOCTOR (NEUROSURGEON) FOR A REVISION. HOWEVER, THE DATE OF THE SURGICAL INTERVENTION WAS UNKNOWN. ACTIONS REQUIRED AS A RESULT OF THE EVENT INCLUDED REPROGRAMMING AND SURGICAL INTERVENTION. THE PRODUCT STATUS OF THE LEAD AS OF THE DATE OF REPORT WAS IMPLANTED AND REMAINS IN SERVICE. DIAGNOSTICS OR TROUBLESHOOTING INCLUDED IMPEDANCE TESTING AND REPROGRAMMING. THE EVENT OCCURRED DURING NORMAL USE. THE CAUSE OF ISSUE WAS SPECIFIED AS >10,000 IMPEDANCES ON FOUR CONTACTS. THE ISSUE WAS NOT RESOLVED. THE PATIENT STATUS AT THE TIME OF THIS REPORT WAS ALIVE WITH NO INJURY. ADDITIONAL INFORMATION WAS REQUESTED BUT WAS NOT AVAILABLE AT THE DATE OF THIS REPORT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    457838 RESTORE ULTRA STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF LGW MEDTRONIC MED REL MEDTRONIC PUERTO RICO 37712

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention