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 Problem Edema (1820)

Event Date 10/07/2019

Event Type  Injury  

Manufacturer Narrative

Additional suspect medical device components involved in the event: model: db-2202-45.Serial/lot: (b)(4).Description: dbs directional lead sterile kit 45cm.

Event Description

A report was received that the patient was held for edema around the leads.

Manufacturer Narrative

Additional information was received that the patient is doing well.There is no physician concern that the edema is on ongoing issue.

Event Description

A report was received that the patient was held for edema around the leads.

• 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: 9238307
• MDR Text Key: 163751187
• Report Number: 3006630150-2019-05981
• 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,health
• Type of Report: Initial,Followup
• Report Date: 11/04/2019

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-2202-45
• Device Catalogue Number: DB-2202-45
• Device Lot Number: 5173446
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 10/07/2019
• Initial Date FDA Received: 10/25/2019
• Supplement Dates Manufacturer Received: 10/24/2019
• Supplement Dates FDA Received: 11/04/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 54 YR