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 Bacterial Infection (1735); Staphylococcus Aureus (2058); No Code Available (3191)

Event Date 12/09/2018

Event Type  Injury  

Manufacturer Narrative

(b)(4).Additional suspect medical device components involved in the event: product family: dbs-linear leads, upn: (b)(4), model: db-2202-45, serial: (b)(4), lot: 5018601.Product family: dbs-ipg-r-mri upn: m365db12000 model: db-1200 serial: 736340 lot: 736340 the physician was unsure of the cause of the infection and the device was not returned for analysis, therefore, the probable cause of the infection cannot be determined.

Event Description

It was reported that the deep brain stimulation patient experienced a staphylococcus aureus infection with discharge at the right cranial wound.The patient was administered antibiotics and underwent a system explant procedure.The physician suspected it could be device and/or procedure related.The devices will not be returned as they were disposed of by the medical facility.

Event Description

It was reported that the deep brain stimulation patient experienced a staphylococcus aureus infection with discharge at the right cranial wound.The patient was administered antibiotics and underwent a system explant procedure.The physician suspected it could be device and/or procedure related.The devices will not be returned as they were disposed of by the medical facility.

Manufacturer Narrative

Correction to the initial mdr in; block b3: date of event block g2: report source- other additional suspect medical device components involved in the event: product family: dbs-linear leads upn: m365db2202450.Model: db-2202-45.Serial: (b)(6).Lot: 5018601.Product family: dbs-ipg-r-mri upn: m365db12000.Model: db-1200.Serial: (b)(6).Lot: 736340.The physician was unsure of the cause of the infection and the device was not returned for analysis, therefore, the probable cause of the infection cannot be determined.

• 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: 11092476
• MDR Text Key: 224741649
• Report Number: 3006630150-2020-06445
• Device Sequence Number: 1
• Product Code: NHL
• UDI-Device Identifier: 08714729905288
• UDI-Public: 08714729905288
• Combination Product (y/n): N
• Reporter Country Code: IS
• PMA/PMN Number: P150031
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,Health Professional,Distributor
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 04/14/2022

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: 01/27/2020
• Device Model Number: DB-2202-45
• Device Catalogue Number: DB-2202-45
• Device Lot Number: 5017789
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 12/13/2020
• Initial Date FDA Received: 12/29/2020
• Supplement Dates Manufacturer Received: 04/06/2022
• Supplement Dates FDA Received: 04/14/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 01/27/2018
• 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): Required Intervention