MAUDE Adverse Event Report: BOSTON SCIENTIFIC NEUROMODULATION

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

Patient Problems Edema (1820); Seizures (2063)

Event Date 08/28/2018

Event Type  Injury  

Manufacturer Narrative

Devices remain implanted.

Event Description

It was reported that a patient was implanted with the vercise dbs system.The patient suffered a seizure and edema.Bacterial cultures (blood and csf) were (b)(4).The patient was treated with antibiotics and steriods.The patient recovered.No further information is available.

• Manufacturer (Section D): BOSTON SCIENTIFIC NEUROMODULATION; 25155 rye canyon loop; valencia CA 91355
• Manufacturer (Section G): BOSTON SCIENTIFIC NEUROMODULATION CORPORATION; 25155 rye canyon loop; valencia CA 91355
• Manufacturer Contact: talar tahmasian ; 25155 rye canyon loop; ,; valencia, CA 91355 ; 6619494863
• MDR Report Key: 7895458
• MDR Text Key: 120962843
• Report Number: 3006630150-2018-60984
• 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,litera
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 09/20/2018

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
• Initial Date Manufacturer Received: 08/28/2018
• Initial Date FDA Received: 09/20/2018
• 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): Required Intervention
• Patient Age: 40 YR