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

Model Number DB-2202-45

Device Problems Unexpected Therapeutic Results (1631); Defective Device (2588)

Patient Problems Fall (1848); Inadequate Pain Relief (2388); Shaking/Tremors (2515); Insufficient Information (4580)

Event Date 06/06/2022

Event Type  Injury  

Event Description

It was reported that the patient hit her head multiple times after suffering from non-device related falls as the stimulation had been off.The patient went to the hospital where it was thought she could have a potential brain bleed or potentially the leads could be broken.The hospital staff discussed obtaining a ct scan but the patient did not have one at this time.The patient called a bsc representative, who walked the patient through restoring programs on the remote control.

Manufacturer Narrative

Additional suspect medical device component involved in the event: product family: dbs-linear leads; upn: m365db2202450; model: db-2202-45; serial: (b)(4); batch: 5130752.

• 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: 14757979
• MDR Text Key: 294841062
• Report Number: 3006630150-2022-03036
• Device Sequence Number: 1
• Product Code: NHL
• UDI-Device Identifier: 08714729905288
• UDI-Public: 08714729905288
• Combination Product (y/n): N
• Reporter Country Code: AS
• PMA/PMN Number: P150031
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,Consumer,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 06/21/2022

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: 04/22/2022
• Device Model Number: DB-2202-45
• Device Catalogue Number: DB-2202-45
• Device Lot Number: 7073805
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 06/06/2022
• Initial Date FDA Received: 06/21/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 04/22/2020
• 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; Other