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

Model Number DB-2202-45

Device Problems Fracture (1260); High impedance (1291)

Patient Problem Fall (1848)

Event Date 06/01/2023

Event Type  malfunction  

Manufacturer Narrative

Additional suspect medical device component involved in the event: product family: dbs-linear leads; upn: m365db2202450; model: db-2202-45; serial: (b)(6); batch: 7073878.

Event Description

It was reported that the deep brain stimulation (dbs) patient experienced a non-device related fall and was informed that her leads were cracked.There were high impedances discovered on contact 8 of the left lead and contact 7 and 8 on the right lead.A computed tomography (ct) scan was performed, and the neurosurgeons assessed there may have been a break in the leads but based on the location of the impedances and how optimally the therapy had been programmed, surgical intervention would not be necessary.Reprogramming was performed and the patient was receiving optimal therapy.

Manufacturer Narrative

Additional suspect medical device component involved in the event: product family: dbs-linear leads, upn: m365db2202450, model: db-2202-45, serial: (b)(6), batch: 7073878.

Event Description

It was reported that the deep brain stimulation (dbs) patient experienced a non-device related fall and was informed that her leads were cracked.There were high impedances discovered on contact 8 of the left lead and contact 7 and 8 on the right lead.A computed tomography (ct) scan was performed, and the neurosurgeons assessed there may have been a break in the leads but based on the location of the impedances and how optimally the therapy had been programmed, surgical intervention would not be necessary.Reprogramming was performed and the patient was receiving optimal therapy.Additional information was received providing the physicians last name, facility name and address.

• 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: 17231597
• MDR Text Key: 318205741
• Report Number: 3006630150-2023-03760
• 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: Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 08/09/2023

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: 03/03/2022
• Device Model Number: DB-2202-45
• Device Catalogue Number: DB-2202-45
• Device Lot Number: 7073040
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 06/02/2023
• Initial Date FDA Received: 06/29/2023
• Supplement Dates Manufacturer Received: 07/14/2023
• Supplement Dates FDA Received: 08/09/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 03/03/2020
• 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: 62 YR
• Patient Sex: Female