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 Abscess (1690); Bacterial Infection (1735); Paralysis (1997); Confusion/ Disorientation (2553); No Code Available (3191)

Event Date 02/21/2020

Event Type  Injury  

Manufacturer Narrative

Additional suspect medical device components involved in the event: model: db-2202-30, serial/ lot: (b)(4), description: dbs directional lead sterile kit 30 cm.Model: nm-3138-55, serial/ lot: (b)(4), description: 55cm 8 contact extension model: nm-3138-55, serial/ lot: (b)(4), description: 55cm 8 contact extension.

Event Description

It was reported that nine days after the implant procedure, the patient experienced consciousness disorder and hemiplegia.A ct scan was performed, which showed an abscess on the right lead.The physician assessed that the patient had an infection with a cyst around the lead.A culture was performed and the results revealed that the patient had klebsiella oxytoca, staphylococcus capitis, and cutis propioni acnes.The patient was treated with antibiotics.The patient underwent a revision procedure and the entire system was explanted.All explanted devices were discarded by the facility.The patient was doing well postoperatively and had completely recovered.

Event Description

It was reported that nine days after the implant procedure, the patient experienced consciousness disorder and hemiplegia.A ct scan was performed, which showed an abscess on the right lead.The physician assessed that the patient had an infection with a cyst around the lead.A culture was performed and the results revealed that the patient had klebsiella oxytoca, staphylococcus capitis, and cutis propioni acnes.The patient was treated with antibiotics.The patient underwent a revision procedure and the entire system was explanted.All explanted devices were discarded by the facility.The patient was doing well postoperatively and had completely recovered.

Manufacturer Narrative

Correction to field a1: patient identifier.Correction to field e1: initial reporter phone.

• 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: 9968891
• MDR Text Key: 188184837
• Report Number: 3006630150-2020-01783
• 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: 08/31/2021

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: 10/29/2021
• Device Model Number: DB-2202-30
• Device Catalogue Number: DB-2202-30
• Device Lot Number: 5180996
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 03/18/2020
• Initial Date FDA Received: 04/16/2020
• Supplement Dates Manufacturer Received: 08/30/2021
• Supplement Dates FDA Received: 08/31/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention