MAUDE Adverse Event Report: BOSTON SCIENTIFIC NEUROMODULATION VERCISE GENUS; STIMULATOR, ELECTRICAL, IMPLANTED, FOR PARKINSONIAN SYMPTOMS

Model Number DB-1216

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

Patient Problems Pneumonia (2011); Septic Shock (2068)

Event Date 06/22/2023

Event Type  Death  

Manufacturer Narrative

Additional suspect medical device components involved in the event: product family: dbs-linear leads: upn: m365db2202450, model: db-2202-45, serial: (b)(6), batch: 7102791.Product family: dbs-linear leads: upn: m365db2202450, model: db-2202-45, serial: (b)(6), batch: 7102956.Product family: dbs-lead fixation: upn: m365db4600c0, model: db-4600c, serial: na, batch: 30994076.Product family: dbs-extension: upn: m365nm3138550, model: nm-3138-55, serial: (b)(6), batch: 7106508.Product family: dbs-extension: upn: m365nm3138550, model: nm-3138-55, serial: (b)(6), batch: 7110248.

Event Description

It was reported that the patient developed pneumonia shortly after the stage two deep brain stimulation (dbs) implant procedure.Although she seemed to have recovered, she later returned to the hospital where the physician assessed her to be suffering from septic shock.The patient passed away shortly thereafter.The physician assessed the event as not related to the device.No further information could be obtained despite good faith efforts.

• Brand Name: VERCISE GENUS
• Type of Device: STIMULATOR, ELECTRICAL, IMPLANTED, FOR PARKINSONIAN SYMPTOMS
• Manufacturer (Section D): BOSTON SCIENTIFIC NEUROMODULATION; 25155 rye canyon loop; valencia CA 91355
• Manufacturer (Section G): BOSTON SCIENTIFIC CORPORATION; cashel road; clonmel ; EI
• Manufacturer Contact: erik sherburne ; 25155 rye canyon loop; valencia, CA 91355 ; 7632920920
• MDR Report Key: 17322902
• MDR Text Key: 319006154
• Report Number: 3006630150-2023-04113
• Device Sequence Number: 1
• Product Code: NHL
• UDI-Device Identifier: 08714729985044
• UDI-Public: 08714729985044
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 07/14/2023

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
• Device Model Number: DB-1216
• Device Catalogue Number: DB-1216
• Device Lot Number: 554181
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 06/28/2023
• Initial Date FDA Received: 07/14/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 11/13/2022
• 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): Death
• Patient Age: 73 YR
• Patient Sex: Female
• Patient Race: White