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 Bacterial Infection (1735); Post Operative Wound Infection (2446)

Event Date 02/10/2021

Event Type  Injury  

Manufacturer Narrative

Additional suspect medical device components involved in the event: product family: dbs-linear leads, upn: (b)(4), model: db-2202-30, serial: (b)(4), batch: 5116865.Product family: dbs-lead fixation.Upn: (b)(4).Model: db-4600c.Serial: null, batch: 23095070.Product family: dbs-linear fixation, upn: (b)(4), model: db-4600c, serial: null, batch: 23105649.

Event Description

It was reported that the patient experienced a wound healing disturbance-infection at the back of the head at the site of the extension cables shortly after the dbs leads implantation procedure.The patient was started on iv antibiotics and an enhanced cranial ct-scan was performed that showed no signs of abscess or other intracranial infection.A culture was taken and showed bacterial growth.The patient underwent an explant procedure to remove the leads, and anchoring devices.Iv antibiotic treatment was continued for 10 more days.The treatment of infection was completed and event resolved.Adverse event a causal relationship to the procedure not related to device.

• 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
• Manufacturer (Section G): BOSTON SCIENTIFIC CORPORATION; road 698, lot no. 12; dorado PR 00646 -260; * 00646-2602
• Manufacturer Contact: talar tahmasian ; 25155 rye canyon loop; valencia, CA 91355 ; 6619494863
• MDR Report Key: 11592050
• MDR Text Key: 243034960
• Report Number: 3006630150-2021-01297
• Device Sequence Number: 1
• Product Code: NHL
• UDI-Device Identifier: 08714729905271
• UDI-Public: 08714729905271
• Combination Product (y/n): N
• Reporter Country Code: GM
• PMA/PMN Number: P150031
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 03/30/2021

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: 01/11/2021
• Device Model Number: DB-2202-30
• Device Catalogue Number: DB-2202-30
• Device Lot Number: 5117528
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 03/17/2021
• Initial Date FDA Received: 03/30/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 01/12/2019
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention