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 Unspecified Infection (1930); Staphylococcus Aureus (2058); No Code Available (3191)

Event Date 06/13/2019

Event Type  Injury  

Event Description

A report was received the patient was undergoing a revision procedure when the physician noted that there were signs of infection at the lead extension connection site.All devices were explanted.

Event Description

A report was received the patient was undergoing a revision procedure when the physician noted that there were signs of infection at the lead extension connection site.All devices were explanted.

Manufacturer Narrative

Additional information was received that two leads and two burr hole covers were explanted.

Manufacturer Narrative

Additional information was received that the burr hole cover and a lead were removed during the explant.It is unclear which burr hole cover was implanted and explanted.It is also unclear which lead was explanted as the patient was implanted with two leads.Additional suspect medical device component involved in the event: brand name: suretek, upn: m365db4600c0, model db-4600c, batch and lot: 22890126, and 22630615.Brand name: vercise cartesia, upn: m365db2202450, model: db-2202-45, serial: (b)(4).The explanted devices were not returned to bsn as they were discarded by the medical facility.A review of the manufacturing documentation for the devices revealed that no anomalies or deviations potentially related to the event occurred during manufacturing.A review of the sterilization documentation for the devices was found to be satisfactory.

Event Description

A report was received the patient was undergoing a revision procedure when the physician noted that there were signs of infection at the lead extension connection site.All devices were explanted.

• 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: 8729522
• MDR Text Key: 149049598
• Report Number: 3006630150-2019-03014
• Device Sequence Number: 1
• Product Code: NHL
• 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,Followup
• Report Date: 09/10/2019

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 Expiration Date: 05/05/2020
• Device Model Number: DB-2202-30
• Device Catalogue Number: DB-2202-30
• Device Lot Number: 7017088
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 06/16/2019
• Initial Date FDA Received: 06/24/2019
• Supplement Dates Manufacturer Received: 07/17/2019; 08/19/2019
• Supplement Dates FDA Received: 08/12/2019; 09/10/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 55 YR