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

Model Number DB-2202-30

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

Patient Problems Tissue Damage (2104); Impaired Healing (2378); Fluid Discharge (2686); No Code Available (3191)

Event Date 03/27/2020

Event Type  Injury  

Event Description

It was reported that at some time in 2020, post implant, the patient developed wound healing disturbance which was moderate in severity.The patient was admitted to the hospital with secretion and sloughing in the area of the left anterior scar.The patient underwent a revision of the left brain lead and received prophylactic treatment with iv antibiotics for 3 days.The patient date of birth is (b)(6), the exact date is unknown.The patient is enrolled in the (b)(6) registry.The event recovered and resolved, and the patient was discharged from the hospital.(b)(6).

Event Description

It was reported that at some time in 2020, post implant, the patient developed wound healing disturbance which was moderate in severity.The patient was admitted to the hospital with secretion and sloughing in the area of the left anterior scar.The patient underwent a revision of the left brain lead and received prophylactic treatment with iv antibiotics for 3 days.The patient date of birth is 1950, the exact date is unknown.The patient is enrolled in the vercise dbs registry.The event recovered and resolved, and the patient was discharged from the hospital.The facility phone number is (b)(6).Additional information was received that the patient had a left and right lead at the time of the event, but only the left lead was repositioned.The model and serial number of the second lead, right lead, is unknown.No devices were explanted during the procedure.

• 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: 10007951
• MDR Text Key: 189581778
• Report Number: 3006630150-2020-01916
• Device Sequence Number: 1
• Product Code: NHL
• UDI-Device Identifier: 08714729905271
• UDI-Public: 08714729905271
• 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: 05/27/2020

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: 10/20/2021
• Device Model Number: DB-2202-30
• Device Catalogue Number: DB-2202-30
• Device Lot Number: 5180076
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 04/10/2020
• Initial Date FDA Received: 04/28/2020
• Supplement Dates Manufacturer Received: 05/06/2020
• Supplement Dates FDA Received: 05/27/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention