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

Model Number MSB_UNK_PROBE

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

Patient Problems Unspecified Infection (1930); Septic Shock (2068)

Event Date 11/30/2020

Event Type  Death  

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.If information is provided in the future, a supplemental report will be issued.

Event Description

Percutaneous image-guided thermal ablation of bone metastases: a retrospective propensity study comparing the safety profile of radio-frequency ablation and cryo-ablation published in international journal of hyperthermia.Summary: study is conducted to retrospectively compare the safety profile of percutaneous image-guided radiofrequency ablation (rfa) and cryoablation (ca) of bone metastases (bm) with and without a propensity score analysis.One patient had septic shock due to an infection of the rfa site leading to patient¿s death.20 patient suffered from pain.2 patients had peripheral sensory or motor neuropathy conclusion: similar low rates of major complications are expected with rfa and ca of bm.In the post-operative period, rfa appears more painful than ca, thus warranting for adoption of dedicated analgesic protocols for patients undergoing rfa.

• Brand Name: OSTEOCOOL RF ABLATION SYSTEM
• Type of Device: ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES
• Manufacturer (Section D): MEDTRONIC SOFAMOR DANEK USA, INC; 4340 swinea rd; memphis TN 38118
• Manufacturer (Section G): MEDTRONIC SOFAMOR DANEK USA, INC; 4340 swinea rd; memphis TN 38118
• Manufacturer Contact: tricha miles ; 1800 pyramid place; memphis, TN 38132 ; 7635140379
• MDR Report Key: 11222384
• MDR Text Key: 228402956
• Report Number: 1030489-2021-00099
• Device Sequence Number: 1
• Product Code: GEI
• Combination Product (y/n): N
• Reporter Country Code: FR
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,literature
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 01/25/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/25/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: MSB_UNK_PROBE
• Device Catalogue Number: MSB_UNK_PROBE
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 01/05/2021
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1
• Patient Outcome(s): Death