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 Problem Intracranial Hemorrhage (1891)

Event Date 04/01/2023

Event Type  Injury  

Event Description

It was reported that the deep brain stimulation (dbs) patient experienced a brain hemorrhage.The patient underwent a revision procedure where the full dbs system was explanted.The patient seemed to have some residual paralysis and was referred to the hospital.The physician assessed that there was a possibility that the hemorrhage was caused by the lead insertion during the implant procedure.The explanted devices were discarded by the facility and were not returned to bsc.

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: 710110.Product family: dbs-linear leads; upn: m365db2202450; model: db-2202-45; serial: (b)(6); batch: 710086.Product family: dbs-extension; upn: m365nm3138550; model: nm-3138-55; serial: (b)(6); batch: 7110094.Product family: dbs-extension; upn: m365nm3138550; model: nm-3138-55; serial: (b)(6); batch: 7109868.Product family: dbs-lead fixation; upn: m365db4600c0; model: db-4600c; serial: (b)(6); batch: 30853166.Product family: dbs-lead fixation; upn: m365db4600c0; model: db-4600c; serial: (b)(6); batch: 30406768.

• 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: 17238196
• MDR Text Key: 318206395
• Report Number: 3006630150-2023-03780
• Device Sequence Number: 1
• Product Code: NHL
• UDI-Device Identifier: 08714729985044
• UDI-Public: 08714729985044
• Combination Product (y/n): N
• Reporter Country Code: JA
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 06/30/2023

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?: Yes
• Device Operator: Lay User/Patient
• Device Model Number: DB-1216
• Device Catalogue Number: DB-1216
• Device Lot Number: 563053
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 06/05/2023
• Initial Date FDA Received: 06/30/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 02/14/2023
• 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: 61 YR
• Patient Sex: Female