MAUDE Adverse Event Report: MEDTRONIC MEXICO KYPHON XPANDER KYPHOPAK TRAY; ARTHROSCOPE

Catalog Number KPT1502

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Arrhythmia (1721)

Event Date 11/14/2019

Event Type  Injury  

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 Description

Pre-op diagnosis: primary osteoporosis type of fracture: compression fracture it was reported that the patient was about to undergo balloon kyphoplasty.Intra-op, while inserting the bone access needle inside the bone and checking the images, the blood pressure of patient increased and arrhythmia occurred.The condition did not recover even after waiting for a few minutes following the anesthesiology direction; hence, the operation was stopped.The cardiology department doctor was called immediately and proper treatment was given.It is planned to perform the operation again when the patient condition recovers the following week.According to the surgeon, the product may have deviated and caused injury to the blood vessel.Patient's current condition is unknown.

• Brand Name: KYPHON XPANDER KYPHOPAK TRAY
• Type of Device: ARTHROSCOPE
• Manufacturer (Section D): MEDTRONIC MEXICO; av. paseo del cucapah #10510; tijuana,bc 22570 ; MX 22570
• Manufacturer (Section G): MEDTRONIC MEXICO; av. paseo del cucapah #10510; tijuana,bc 22570 ; MX 22570
• Manufacturer Contact: stacie ziemba ; 1800 pyramid place; memphis, TN 38132 ; 9013963133
• MDR Report Key: 9469660
• MDR Text Key: 179280558
• Report Number: 9612164-2019-05169
• Device Sequence Number: 1
• Product Code: HRX
• UDI-Device Identifier: 00763000031725
• UDI-Public: 00763000031725
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: K041454
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 12/13/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/13/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: KPT1502
• Device Lot Number: 217407114
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 11/14/2019
• Was Device Evaluated by Manufacturer?: No
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Other