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 Bradycardia (1751); Cerebrospinal Fluid Leakage (1772); Vomiting (2144)

Event Date 08/13/2020

Event Type  Injury  

Event Description

It was reported that the patient underwent a stage 1 dbs implant procedure and the patient experienced bradycardia and vomited during the procedure.The patient lost a lot of cerebrospinal fluid during the procedure and the physician did not feel comfortable proceeding with the second side implant due to possible brain shift.The right side procedure was aborted and the burr hole cover was implanted.No other interventions were given during the procedure.The patient had a postoperative ct scan, which showed no bleeding.The patient fully recovered and the stage 2 procedure was completed a week later to implant the ipg and connect to the single lead that was implanted.The second lead was never opened during the stage 1 implant procedure, so there is no product expected to be returned.

• 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: 10495062
• MDR Text Key: 205705979
• Report Number: 3006630150-2020-03931
• 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: 09/04/2020

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?: No
• Device Operator: Lay User/Patient
• Device Expiration Date: 05/26/2022
• Device Model Number: DB-2202-45
• Device Catalogue Number: DB-2202-45
• Device Lot Number: 7073906
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 08/13/2020
• Initial Date FDA Received: 09/04/2020
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 05/26/2020
• 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): Required Intervention
• Patient Age: 70 YR