BEUDAMED
    FDA Adverse Event Injury Summary report: N

    RESTORE ADVANCED

    MDR report key: 3352288 · Received September 17, 2013

    Report

    Report Number
    3004209178-2013-16361
    Event Type
    Injury
    Date Received
    September 17, 2013
    Report Date
    August 22, 2013
    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
    MD, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    CONCOMITANT MEDICAL PRODUCTS: PRODUCT ID 39565-30, SERIAL# (B)(4), IMPLANTED: (B)(6) 2007. PRODUCT TYPE: LEAD: PRODUCT ID 3708140, SERIAL# (B)(4), IMPLANTED: (B)(6) 2007. PRODUCT TYPE: EXTENSION: PRODUCT ID 3708140, SERIAL# (B)(4), IMPLANTED: (B)(6) 2007. PRODUCT TYPE: EXTENSION. (B)(4).

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION RECEIVED REPORTED THAT IN (B)(6) 2013, AFTER REMOVAL, THE PATIENT DID NOT REPORT ANY CHANGE IN THEIR NAUSEA. THE PATIENT DID REPORT AN IMPROVEMENT OF THE PAIN IN THEIR BUTTOCK AREA. THE PATIENT HAD NO WOUND HEALING DIFFICULTIES. THE INCISIONS WERE WELL HEALED AND THERE WERE NO NEW DEFICITS. THE PATIENT WAS DOING WELL AFTER REMOVAL OF THE INS. IN (B)(6) 2013 IT WAS NOTED THAT THE INS GAVE THE PATIENT A DEGREE OF RELIEF OF THEIR BILATERAL LEGS, BUT NEVER REALLY HELPED THE LUMBAR, THORACIC OR CERVICAL SPINE PAIN. IT WAS NOTED THE PAIN WAS VERY BOTHERSOME. IT WAS NOTED THAT THE PATIENT WOULD NOT HAVE EPISODES OF EMESIS WHEN THE STIMULATION WAS TURNED OFF. THE PATIENT WOULD OCCASIONALLY USE THE STIMULATOR FOR PAIN BUT DISCONTINUED REGULAR USE. THE PATIENT¿S LUMBAR SPINE HAD A LIMITED RANGE OF MOTION AND WAS TENDER TO PALPATION. AFTER A THOROUGH DISCUSSION OF ALL THE OPTIONS THE PATIENT ELECTED TO PROCEED WITH THE SURGERY TO REMOVE THE INS. IN (B)(6) 2007, THE PATIENT CONTINUED GOOD COVERAGE OF THEIR LEG PAIN. AT THAT TIME THEY NOTED THAT THE BACK PAIN WAS LESS WELL COVERED BUT WAS STABLE TO INITIAL COVERAGE LEVEL. AT THAT TIME IT WAS ALSO NOTED ALSO THAT THE PATIENT HAD NO WOUND HEALING DIFFICULTIES AND THEIR INCISIONS HEALED WELL. IT WAS FURTHER NOTED THAT THE PATIENT HAD A GOOD RESPONSE TO THE STIMULATOR. IN (B)(6) 2007 THE PATIENT HAD ¿EXCELLENT¿ COVERAGE OF THEIR PAIN WITH THE STIMULATOR. PRIOR TO THE PERMANENT IMPLANT, THE PATIENT HAD GRADUALLY WORSENING LOW BACK PAIN AND A CONSTANT BURNING SENSATION WHICH AFFECTED THE WHOLE LEG. IN ADDITION, THEIR GATE HAD SLOWED AND THE PATIENT USED A CANE FOR AMBULATION. IT WAS NOTED THAT X-RAYS WERE PERFORMED. IT WAS NOTED THAT THE PATIENT HAD TWO PRIOR LUMBAR DECOMPRESSIVE SURGERIES, LIDOCAINE PATCHES, OPOIDS, LYRICA, NONSTEROIDAL ANTI-INFLAMMATORY AGENTS, AND PHYSICAL THERAPY WHICH ALL YIELDED MIXED RESULTS. THE PATIENT HAD HIGH BLOOD PRESSURE, A HISTORY OF THYROID CANCER, SLEEP APNEA, GASTROESOPHAGEAL REFLUX DISEASE AND A HISTORY OF KIDNEY STONES. THE PATIENT SMOKED APPROXIMATELY 10 CIGARS A DAY AND DRANK ALCOHOL WITH DINNER. ADDITIONAL INFORMATION RECEIVED REPORTED THAT THE LEAD AND INS WERE REMOVED. IT WAS NOTED THAT THE INS WAS PROVIDING THE PATIENT RELIEF BUT AT SOME POINT IT QUIT PROVIDING RELIEF OF THEIR PAIN. THE PATIENT FELT THAT IT WAS CAUSING LOCAL DISCOMFORT AND WAS VERY DESIROUS OF REMOVING IT.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT STRUGGLED WITH WEIGHT LOSS AND VOMITING WHEN STIMULATION WAS ON. THE PATIENT STATED THAT HE WOULD EAT AND THEN THROW UP. THE PATIENT STATED THAT HE LOST 50 LBS IN LESS THAN SIX MONTHS. THE PATIENT STATED THAT THE DEVICE HELPED WITH SOME OF HIS PAIN, BUT WHEN HE COUGHED OR SNEEZED, HE FELT STIMULATION INCREASE OR DECREASE. THE PATIENT STATED THAT FOLLOWING THE WEIGHT LOSS, HE FELT PAIN AT THE IMPLANTABLE NEUROSTIMULATOR (INS) SITE AND IT BOTHERED HIM. THE PATIENT ALSO STATED THAT HIS ABDOMEN MUSCLES WERE CRAMPED, KNOTTED UP AND IRRITATED. THE PATIENT REPORTEDLY HAD THE INS REMOVED. IT WAS NOTED THAT FOLLOWING THE EXPLANT THE PATIENT WAS UNABLE TO GAIN WEIGHT. ADDITIONAL INFORMATION WAS REQUESTED BUT WAS NOT AVAILABLE AS OF THE DATE OF THIS REPORT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    467165 RESTORE ADVANCED STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF LGW MEDTRONIC MED REL MEDTRONIC PUERTO RICO 37713

    Patients

    Seq Age Sex Outcome Treatment
    1 00055 YR Required Intervention