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

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

Patient Problem Pneumonia (2011)

Event Date 04/19/2018

Event Type  Injury  

Manufacturer Narrative

Expiration date: ni.(b)(6).

Event Description

A report was received that the patient, who is enrolled in the (b)(6) clinical study, developed pneumonia which was moderate in severity and prolonged the patients hospitalization.The patient was treated with antibiotics and recovered and the event resolved.The event was assessed as having a possible relationship to the procedure and not related to the hardware or stimulation.

Event Description

A report was received that the patient, who is enrolled in the vercise dbs registry clinical study, developed pneumonia which was moderate in severity and prolonged the patients hospitalization.The patient was treated with antibiotics and recovered and the event resolved.The event was assessed as having a possible relationship to the procedure and not related to the hardware or stimulation.

Manufacturer Narrative

Additional information was received that because the event was assessed as not related to the device no additional information is provided per clinical study protocol.

Event Description

A report was received that the patient, who is enrolled in the vercise dbs registry clinical study, developed pneumonia which was moderate in severity and prolonged the patients hospitalization.The patient was treated with antibiotics and recovered and the event resolved.The event was assessed as having a possible relationship to the procedure and not related to the hardware or 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: 7586660
• MDR Text Key: 110605138
• Report Number: 3006630150-2018-02098
• 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: 06/19/2018

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: 05/29/2018
• Initial Date FDA Received: 06/11/2018
• Supplement Dates Manufacturer Received: 05/29/2018; 06/12/2018
• Supplement Dates FDA Received: 06/11/2018; 06/19/2018
• 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): Hospitalization; Required Intervention