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

Model Number DB-2202-45

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

Patient Problems Edema (1820); No Code Available (3191)

Event Date 01/20/2020

Event Type  Injury  

Manufacturer Narrative

Additional suspect medical device components involved in the event: product family: dbs-linear leads, upn: (b)(4), model: db-2202-45, serial: (b)(4), batch: 5173747.

Event Description

A report was received that a patient enrolled in the (b)(6) study a4012 experienced frontal bilateral proximal peri-lead edema 5 days post-implant.Medication was administered and the edema was resolving.Patient was in good clinical condition post medical intervention.

Event Description

A report was received that a patient enrolled in the vercise dbs dystonia registry study (b)(6) experienced frontal bilateral proximal peri-lead edema 5 days post-implant.Medication was administered and the edema was resolving.Patient was in good clinical condition post medical intervention.The edema was assessed to be related to the procedure and not related to the device or stimulation.

Manufacturer Narrative

Correction to initial mdr in section b5.

• Brand Name: VERCISE CARTESIA
• Type of Device: STIMULATOR, ELECTRICAL, IMPLANTED, FOR PARKINSONIAN SYMPTOMS
• Manufacturer (Section D): BOSTON SCIENTIFIC NEUROMODULATION; 25155 rye canyon loop; valencia CA 91355
• MDR Report Key: 9751160
• MDR Text Key: 187926332
• Report Number: 3006630150-2020-00774
• Device Sequence Number: 1
• Product Code: NHL
• UDI-Device Identifier: 08714729905288
• UDI-Public: 08714729905288
• 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: 03/27/2020

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?: No
• Device Operator: Lay User/Patient
• Device Expiration Date: 05/23/2021
• Device Model Number: DB-2202-45
• Device Catalogue Number: DB-2202-45
• Device Lot Number: 5150009
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 01/28/2020
• Initial Date FDA Received: 02/25/2020
• Supplement Dates Manufacturer Received: 03/26/2020
• Supplement Dates FDA Received: 03/27/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention