MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a foreign,health professional,s report with the FDA on 2020-03-18 for manufactured by Boston Scientific Neuromodulation.

Event Text Entries

[183941627] Date of birth: (b)(6), (exact date unknown).
Patient Sequence No: 1, Text Type: N, H10

[183941628] It was reported that during an intra operative procedure the patient experienced a severe venous coagulation due to an air emboly. During the procedure there was relevant bleeding when the dura was opened and normalized with medication and coagulation of the vessel. The patient recovered and was released from the hospital.
Patient Sequence No: 1, Text Type: D, B5

MAUDE Entry Details

• Report Number: 3006630150-2020-01229
• MDR Report Key: 9849096
• Report Source: FOREIGN,HEALTH PROFESSIONAL,S
• Date Received: 2020-03-18
• Date of Report: 2020-03-18
• Date of Event: 2020-02-19
• Date Mfgr Received: 2020-02-28
• Date Added to Maude: 2020-03-18
• Event Key: 0
• Report Source Code: Manufacturer report
• Manufacturer Link: Y
• Number of Patients in Event: 0
• Adverse Event Flag: 3
• Product Problem Flag: 3
• Reprocessed and Reused Flag: 3
• Health Professional: 3
• Initial Report to FDA: 3
• Report to FDA: 3
• Event Location: 3
• Manufacturer Contact: TALAR TAHMASIAN
• Manufacturer Street: 25155 RYE CANYON LOOP
• Manufacturer City: VALENCIA CA 91355
• Manufacturer Country: US
• Manufacturer Postal: 91355
• Manufacturer Phone: 6619494863
• Single Use: 3
• Previous Use Code: 3
• Event Type: 3
• Type of Report: 3

Device Details

• Product Code: NHL
• Date Received: 2020-03-18
• Operator: HEALTH PROFESSIONAL
• Device Availability: N
• Device Eval'ed by Mfgr: R
• Device Sequence No: 1
• Device Event Key: 0
• Manufacturer: BOSTON SCIENTIFIC NEUROMODULATION
• Manufacturer Address: 25155 RYE CANYON LOOP VALENCIA CA 91355 US 91355

Patients

Patient Number	Treatment	Outcome	Date
1	0	1. Hospitalization; 2. Other	2020-03-18