MAUDE Adverse Event Report: BOSTON SCIENTIFIC NEUROMODULATION

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

Patient Problems Edema (1820); Confusion/ Disorientation (2553); No Code Available (3191)

Event Date 10/22/2020

Event Type  Injury  

Manufacturer Narrative

Date of birth (b)(6), exact patient date of birth is unknown.(b)(4).

Event Description

It was reported that fourteen days after undergoing an implant procedure, the patient experienced a peri-lead edematous reaction and confusion, which was severe.A head ct scan showed hypodense white matter changes around the puncture channel on both sides, with more changes on the left side than the right side.The patient was given medication and had a prolonged hospitalization from the surgery.It was reported that the event is resolving; and that the physician assessed this event to have a probable relationship to the procedure, possibly related to device stimulation, and not related to device hardware.

Event Description

It was reported that fourteen days after undergoing an implant procedure, the clinical patient, study a4010 vercise dbs registry, experienced a peri-lead edematous reaction and confusion, which was severe.A head ct scan showed hypodense white matter changes around the puncture channel on both sides, with more changes on the left side than the right side.The patient was given medication and had a prolonged hospitalization from the surgery.It was reported that the event is resolving; and that the physician assessed this event to have a probable relationship to the procedure, possibly related to device stimulation, and not related to device hardware.This event was previously reported.See mfr.Report # 3006630150-2020-05729 and 3006630150-2020-05729.

• Manufacturer (Section D): BOSTON SCIENTIFIC NEUROMODULATION; 25155 rye canyon loop; valencia CA 91355
• MDR Report Key: 10994699
• MDR Text Key: 221241794
• Report Number: 3006630150-2020-06165
• Device Sequence Number: 1
• Product Code: NHL
• Combination Product (y/n): N
• PMA/PMN Number: P150031
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup
• Report Date: 12/23/2020

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?: Yes
• Device Operator: Lay User/Patient
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 11/19/2020
• Initial Date FDA Received: 12/12/2020
• Supplement Dates Manufacturer Received: 12/16/2020
• Supplement Dates FDA Received: 12/23/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 64 YR