MAUDE Adverse Event Report: BOSTON SCIENTIFIC NEUROMODULATION; DEEP BRAIN STIMULATOR

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

Patient Problem Atrial Fibrillation (1729)

Event Date 07/27/2016

Event Type  Injury  

Event Description

A report was received that the patient, during the implant procedure and during post-operative monitoring, experienced intermittent atrial fibrillation several times.It was decided that patient required oral anticoagulation and it was recommend that he be started postoperatively for four weeks as outpatient treatment.The event was assessed as unlikely related to study procedure, hardware and stimulation.

Manufacturer Narrative

Additional information was received that per the clinical study site, the event was reassessed as not related to the device, and there is no device component or device type potentially related to the event therefore the device information is not provided.

Event Description

A report was received that the patient, during the implant procedure and during post-operative monitoring, experienced intermittent atrial fibrillation several times.It was decided that patient required oral anticoagulation and it was recommend that he be started postoperatively for four weeks as outpatient treatment.The event was assessed as unlikely related to study procedure, hardware and stimulation.

Manufacturer Narrative

Additional information was received that per the investigator the event was not related to the procedure, device or stimulation.

Event Description

A report was received that the patient, during the implant procedure and during post-operative monitoring, experienced intermittent atrial fibrillation several times.It was decided that patient required oral anticoagulation and it was recommend that he be started postoperatively for four weeks as outpatient treatment.The event was assessed as unlikely related to study procedure, hardware and stimulation.

• Type of Device: DEEP BRAIN STIMULATOR
• Manufacturer (Section D): BOSTON SCIENTIFIC NEUROMODULATION; 25155 rye canyon loop; valencia CA 91355
• Manufacturer (Section G): 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: 7527789
• MDR Text Key: 108719324
• Report Number: 3006630150-2018-01764
• Device Sequence Number: 1
• Product Code: NHL
• Combination Product (y/n): N
• Reporter Country Code: GM
• PMA/PMN Number: 150031
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date: 09/04/2018

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
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 04/27/2018
• Initial Date FDA Received: 05/18/2018
• Supplement Dates Manufacturer Received: 05/25/2018; 08/15/2018
• Supplement Dates FDA Received: 06/04/2018; 09/04/2018
• 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: 65 YR