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 Problems Erosion (1750); Pain (1994); Staphylococcus Aureus (2058); Impaired Healing (2378); Fluid Discharge (2686); No Code Available (3191)

Event Date 12/05/2020

Event Type  Injury  

Manufacturer Narrative

(b)(4).Additional suspect medical device components involved: product family: dbs-linear leads, upn: (b)(4), model: db-2202-45, serial: (b)(4), batch: 5177555.Product family: dbs-extension, upn: (b)(4), model: nm-3138-55, serial: (b)(4), batch: 7075864.Product family: dbs-extension, upn: (b)(4), model: nm-3138-55, serial: (b)(4), batch: 7075690.

Event Description

It was reported that the patient was complaining of pain and the neurologist noticed the incision on the top of the skull was weeping, and also found erosion near the connection point between the lead and extension.A culture was taken and was diagnosed as a staphylococcus aureus infection.The neurosurgeon ordered imaging and advised surgical exploration of the infection and prescribed antibiotics.The patient was admitted to hospital wherein he underwent an antibiotic washout of the skull surface and a procedure to relocate the connection between the leads and extensions to another part of the skull with thicker tissue.After the washout and relocating the connection between the leads and extensions, the patient was noted to be doing well following the procedure and was discharged from the hospital.

• 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; RQ 00646-2602
• Manufacturer Contact: talar tahmasian ; 25155 rye canyon loop; valencia, CA 91355 ; 6619494863
• MDR Report Key: 11031741
• MDR Text Key: 222275477
• Report Number: 3006630150-2020-06256
• Device Sequence Number: 1
• Product Code: NHL
• UDI-Device Identifier: 08714729905288
• UDI-Public: 08714729905288
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P150031
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 12/17/2020

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?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 01/07/2022
• Device Model Number: DB-2202-45
• Device Catalogue Number: DB-2202-45
• Device Lot Number: 7071659
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 12/05/2020
• Initial Date FDA Received: 12/17/2020
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 01/08/2020
• 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
• Patient Age: 65 YR