MAUDE Adverse Event Report: BOSTON SCIENTIFIC NEUROMODULATION

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

Patient Problems Cardiac Arrest (1762); Insufficient Information (4580)

Event Date 05/06/2021

Event Type  Death  

Event Description

It was reported that during the implant procedure the patient was administered anesthesia, and while the patient was intubated and as soon as she was placed in the prone position, the patient had a cardiac arrest and a cardiopulmonary resuscitation was started.The surgery had not begun and no product was opened or used.The patient was taken to the catheterization laboratory and she passed away in the intensive care unit the same day.The patient had significant past medical history including hypertension, chronic obstructive pulmonary disease, coronary artery disease and diabetes.She was seen by cardiology the week before surgery and was cleared for surgery.An autopsy will not be performed.

• Manufacturer (Section D): BOSTON SCIENTIFIC NEUROMODULATION; 25155 rye canyon loop; valencia CA 91355
• Manufacturer Contact: talar tahmasian ; 25155 rye canyon loop; valencia, CA 91355 ; 6619494863
• MDR Report Key: 11901256
• MDR Text Key: 253197731
• Report Number: 3006630150-2021-02474
• Device Sequence Number: 1
• Product Code: NHL
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P150031
• 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: 05/28/2021

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: Lay User/Patient
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 05/06/2021
• Initial Date FDA Received: 05/28/2021
• 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): Death
• Patient Age: 73 YR