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 Nausea (1970); Vomiting (2144); Dizziness (2194)

Event Date 07/05/2020

Event Type  Injury  

Manufacturer Narrative

Additional suspect medical device component involved in the event: product family: dbs-linear leads, upn: m365db2202300, model: db-2202-30, serial: (b)(4), batch: 7071098.

Event Description

It was reported that the clinical study patient developed rotary vertigo which was moderate in severity and was admitted to the hospital.The event resolved and the patient was discharged.The physician assessed that the event was unlikely related to the device and was not related to the stimulation or the procedure.

Event Description

It was reported that the clinical study patient developed rotary vertigo which was moderate in severity and was admitted to the hospital.The event resolved and the patient was discharged.The physician assessed that the event was unlikely related to the device and was not related to the stimulation or the procedure.Additional information was received that the patient's symptoms included nausea and vomiting.While in the hospital the patient was treated with medication and physical therapy.The physician assessed that the event was unlikely related to the device and procedure and was not related to the stimulation.

• 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: erik sherburne ; 25155 rye canyon loop; valencia, CA 91355 ; 7632920920
• MDR Report Key: 15068270
• MDR Text Key: 296260537
• Report Number: 3006630150-2022-03562
• 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: Other,Foreign,Study,Health Professional
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 12/08/2022

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: 01/29/2022
• Device Model Number: DB-2202-30
• Device Catalogue Number: DB-2202-30
• Device Lot Number: 7071096
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 06/25/2022
• Initial Date FDA Received: 07/20/2022
• Supplement Dates Manufacturer Received: 11/16/2022
• Supplement Dates FDA Received: 12/08/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 01/30/2020
• 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; Hospitalization