MAUDE Adverse Event Report: MEDTRONIC SOFAMOR DANEK USA, INC OSTEOCOOL RF ABLATION SYSTEM; ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES

Catalog Number	OCP215
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Diminished Pulse Pressure (2606)
Date of Event	06/14/2019
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
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.Although it is unknown whether this product caused or contributed to the reported event, we are filling this mdr for notification purpose.If information is provided in the future, a supplemental report will be issued.
Event or Problem Description
It was reported that the patient was undergoing ablation followed by kyphoplasty at t10 and t11 due to metastatic tumor.Intra-op, patient¿s blood pressure and heart rate started to drop in the middle of second level ablation (after 1hour and 20minutes into the procedure).The anesthesia was reversed and fluids were given to her but both parameters continued to drop; and eventually, the patient coded after second level ablation was completed.Rapid response team was called and she was brought back after her heart stopped.Patient was sent to the icu without ballooning or cementing.Patient had coded 2 days prior to the case, but was cleared by cardiology.Both levels were ablated but no ballooning or cementing have been done.According to the physician, the adverse event was related to patient's medical condition and not procedural related.On (b)(6) 2019, the patient was still in icu but awake and responsive.No additional surgery has been scheduled yet.No patient complications have been reported since the operation.
Additional Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.

• Brand Name: OSTEOCOOL RF ABLATION SYSTEM
• Common Device Name: ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES
• Manufacturer (Section D): MEDTRONIC SOFAMOR DANEK USA, INC; 4340 swinea rd; memphis TN 38118
• MDR Report Key: 8787393
• Report Number: 1030489-2019-00759
• Device Sequence Number: 1689501
• Product Code: GEI
• UDI-Device Identifier: 00643169871625
• UDI-Public: 00643169871625
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• PMA/510(K) Number: K152057
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 07/13/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Health Professional
• Device Expiration Date: 10/28/2022
• Device Catalogue Number: OCP215
• Device Lot Number: BY18L004
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 06/14/2019
• Supplement Date Received by Manufacturer: 06/14/2019
• Initial Report FDA Received Date: 07/13/2019
• Supplement Report FDA Received Date: 07/13/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Age: 68 YR