MAUDE Adverse Event Report: NEUROTHERM, INC NEUROTHERM¿ SL PREMIUM CURVED RF NEEDLE, 20G, 15CM; RF CANNULA

Model Number SL-C1510-20

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

Patient Problems Cardiac Arrest (1762); Hemorrhage/Bleeding (1888)

Event Date 10/31/2017

Event Type  Injury  

Manufacturer Narrative

The reported event was for patient bleeding and a cardiac arrest.The results of the investigation are inconclusive since the device was not returned for analysis.Based on the information received, the cause of the reported bleeding and cardiac arrest may have been procedure related.

Event Description

During a trigeminal nerve ablation procedure, the patient went into cardiac arrest.During needle placement the patient began bleeding from the head and neck and went into cardiac arrest.The patient was resuscitated and admitted to the icu.There were no performance issues with any abbott device.Further information has been requested but is not available.

• Brand Name: NEUROTHERM¿ SL PREMIUM CURVED RF NEEDLE, 20G, 15CM
• Type of Device: RF CANNULA
• Manufacturer (Section D): NEUROTHERM, INC; 600 research drive ste 1; wilmington MA 01887
• Manufacturer (Section G): NEUROTHERM, INC; 600 research drive ste 1; wilmington MA 01887
• Manufacturer Contact: denise johnson ; 5050 nathan lane north; plymouth, MN 55442 ; 6517564470
• MDR Report Key: 7010047
• MDR Text Key: 91351816
• Report Number: 3002953813-2017-00039
• Device Sequence Number: 1
• Product Code: GXI
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K000073
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 11/08/2017

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
• Device Operator: Health Professional
• Device Model Number: SL-C1510-20
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 10/31/2017
• Initial Date FDA Received: 11/08/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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): Life Threatening