BEUDAMED
    FDA Adverse Event Injury Summary report: N

    RESTORE ULTRA

    MDR report key: 2614186 · Received June 12, 2012

    Report

    Report Number
    3004209178-2012-04381
    Event Type
    Injury
    Date Received
    June 12, 2012
    Date of Event
    April 16, 2012
    Report Date
    May 16, 2012
    Manufacturer
    MDT PUERTO RICO OPERATIONS CO
    Product Code
    LGW
    PMA / PMN Number
    P840001
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    ID, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    PRODUCT ID 39565-65, SERIAL# (B)(4), IMPLANTED: 2010-(B)(6), PRODUCT TYP LEAD PRODUCT ID 37752, SERIAL# (B)(4), PRODUCT TYP RECHARGER PRODUCT ID 37743, SERIAL# (B)(4), PRODUCT TYP PROGRAMMER, PATIENT PRODUCT ID 37092, LOT# 260850001, IMPLANTED: 2010-(B)(6), EXPLANTED: PRODUCT TYP ACCESSORY, PRODUCT ID 3708140, , SERIAL# (B)(4), IMPLANTED: 2012-(B)(6), EXPLANTED: PRODUCT TYP EXTENSION PRODUCT ID 3708140, SERIAL# (B)(4) IMPLANTED: 2012-(B)(6), EXPLANTED: PRODUCT TYP EXTENSION PRODUCT ID 3550-45, LOT# N243346, IMPLANTED: 2012-(B)(6), EXPLANTED: PRODUCT TYP ACCESSORY. (B)(4).

    Additional Manufacturer Narrative · 1

    ANALYSIS OF DEVICE, MODEL# 37712, SERIAL # (B)(4), FOUND THE BATTERY HAD REDUCED CAPACITY DUE TO OVERDISCHARGE. NO SIGNIFICANT ANOMALIES. ACCORDING TO THE TRACE REPORT, THE COUPLING RANGED FROM 0 TO 6 BARS ON FIVE OF THE LAST SIX RECHARGE SESSIONS. THE INS WAS RECHARGED A TOTAL OF 19 MINUTES 41 SECONDS FROM (B)(6) 2012 TO (B)(6) 2012.

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION RECEIVED REPORTED THAT THE PATIENT'S INTERNAL NEUROSTIMULATOR (INS) WAS REPLACED ON (B)(6) 2012. IT WAS NOTED THAT ALL THE IMPEDANCES WITH THE NEW BATTERY WERE WITHIN NORMAL LIMITS, SO NO LEAD CHANGE OR EXTENSION CHANGE WAS NECESSARY. IT WAS FURTHER NOTED THAT THE "PATIENT WAS UNDER GENERAL ANESTHESIA DURING SURGERY, SO THE STIMULATION DID NOT TAKE PLACE INTRA-OPERATIVELY." THE MANUFACTURING REPRESENTATIVE PROGRAMED THE PATIENT IN RECOVERY, BUT IT WAS NOTED THAT THE PATIENT WAS "QUITE GROGGY." IT WAS NOTED THAT THE PATIENT WAS INSTRUCTED TO CONTACT THE MANUFACTURER IF SHE NEEDED REPROGRAMMING. THE MANUFACTURING REPRESENTATIVE STATED THAT "WHEN THE PHYSICIAN OPENED THE POCKET, THE INS APPEARED TO BE PERPENDICULAR TO THE PATIENT'S SKIN." IT WAS FURTHER INDICATED THAT THIS COULD HAVE BEEN THE REASON WHY THE PATIENT WAS UNABLE TO RECHARGE THE DEVICE.

    Description of Event or Problem · 1

    IT WAS REPORTED THE IMPLANTABLE NEUROSTIMULATOR (INS) WAS RELOCATED FROM THE PATIENT'S BUTTOCK TO THE ABDOMEN. THE PATIENT HAD DIFFICULTY RECHARGING (NO BLACK BOXES WERE SHOWING) WITH INS IN ABDOMEN. THE MANUFACTURER REPRESENTATIVE COULD NOT RECHARGE INS. THERE WAS NO SWELLING AT THE INS SITE AND THE INCISION WAS HEALED. PATIENT OUTCOME WAS NOT PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 RESTORE ULTRA STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF LGW MDT PUERTO RICO OPERATIONS CO 37712

    Patients

    Seq Age Sex Outcome Treatment
    1 51 YR Required Intervention