UNKNOWN

Description of Event or Problem

LITERATURE WAS REVIEWED REGARDING RADIATION THERAPY (RT) ALONE VERSUS RT PLUS RADIOFREQUENCY ABLATION/VERTEBRAL AUGMENTATION FOR PAINFUL SPINE METASTASIS: A PHASE 2 RANDOMIZED CONTROLLED TRIAL. MULTIPLE MANUFACTURER¿S DEVICES WERE IMPLANTED IN THE STUDY POPULATION. THE FOLLOWING MEDTRONIC DEVICES WERE USED: OSTEOCOOL RF ABLATION SYSTEM AND KYPHOPLASTY BALLOON AUGMENTATION FOLLOWED BY KYPHON HIGH-VISCOSITY BONE CEMENT. DEATHS OCCURRED IN THE STUDY POPULATION; HOWEVER, THERE WAS NO STATEMENT ESTABLISHING A CAUSAL OR CONTRIBUTORY RELATIONSHIP BETWEEN MEDTRONIC PRODUCT AND THE DEATHS. THE CAUSES OF DEATH WERE, TWO DEATHS DUE TO CARDIAC ARREST OCCURRED, ONE IN EACH ARM, AND WERE DEEMED UNRELATED TO STUDY TREATMENTS. AMONG OSTEOCOOL RF ABLATION SYSTEM, KYPHOPLASTY BALLOON AUGMENTATION AND KYPHON HIGH-VISCOSITY BONE CEMENT, NO DEVICE MALFUNCTION, FAILURE, OR PERFORMANCE ISSUE WAS REPORTED. AND PATIENTS' ADVERSE EVENTS ISSUES REPORTED IN THE STUDY INCLUDED DYSPHAGIA, ESOPHAGITIS, NAUSEA, WEAKNESS, BACK PAIN, ABSCESS, SPINAL COMPRESSION FRACTURE, AND SPINAL CORD COMPRESSION SECONDARY TO VERTEBRAL FRACTURE. NO FURTHER INFORMATION WAS PROVIDED PERTAINING TO MEDTRONIC PRODUCTS.

Additional Manufacturer Narrative

ARTICLE CITATION INCLUDING WEB ADDRESS/LITERATURE REFERENCE (DOI): RUPESH KOTECHA, OMER GAL, HALEY APPEL, MARIA CAROLINA AVENDANO, ANTOINETTE M. PIMENTEL, AMY K. STAROSCIAK, MUNI RUBENS, MUKESH ROY, DILANIS PERCHE, CRISTINA I. POW-SANG, FABIANA MILOSEVIC, RAMON F. C. DOI: HTTPS://DOI.ORG/10.1093/NEUONC/NOAF231 A.2. THIS VALUE IS THE AVERAGE AGE OF THE PATIENTS REPORTED IN THE ARTICLE AS SPECIFIC PATIENTS COULD NOT BE IDENTIFIED. A.3. THIS VALUE REFLECTS THE GENDER OF THE MAJORITY OF THE PATIENTS REPORTED IN THE ARTICLE AS SPECIFIC PATIENTS COULD NOT BE IDENTIFIED. B2: OUTCOME ATTRIBUTED TO ADVERSE EVENT IS FRACTURE. B3.PLEASE NOTE THAT THIS DATE IS BASED OFF OF THE DATE OF PUBLICATION/ACCEPTANCE OF ARTICLE AS THE EVENT DATES WERE NOT PROVIDED IN THE PUBLISHED ARTICLE. D1, D2 & D4: PRODUCT IDENTIFIER IS UNKNOWN. G4: PRODUCT IDENTIFIER IS UNKNOWN, HENCE 510K# IS NOT AVAILABLE. H6: NEITHER THE DEVICE NOR FILMS OF APPLICABLE IMAGING STUDIES WERE RETURNED TO THE MANUFACTURER FOR EVALUATION. THEREFORE, WE ARE UNABLE TO DETERMINE THE DEFINITIVE CAUSE OF THE REPORTED EVENT. 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.