MAUDE Adverse Event Report: BOSTON SCIENTIFIC NEUROMODULATION VERCISE CARTESIA; STIMULATOR, ELECTRICAL, IMPLANTED, FOR PARKINSONIAN SYMPTOMS

Model Number DB-2202-45

Device Problem Defective Device (2588)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 11/18/2022

Event Type  Injury  

Event Description

It was reported that the patient underwent a deep brain stimulation (dbs) lead replacement procedure due to an unknown device failure and a new lead was implanted.The lead will not be returned for analysis as it was disposed of by the facility.No further information has been obtained despite good-faith efforts.

• 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: 16040171
• MDR Text Key: 306061792
• Report Number: 3006630150-2022-07199
• Device Sequence Number: 1
• Product Code: NHL
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: P150031
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 12/22/2022

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?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 08/29/2022
• Device Model Number: DB-2202-45
• Device Catalogue Number: DB-2202-45
• Device Lot Number: 7076148
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 12/02/2022
• Initial Date FDA Received: 12/22/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 08/29/2020
• 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 Sex: Female