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

Model Number DB-2202-30

Device Problems Inappropriate/Inadequate Shock/Stimulation (1574); Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Undesired Nerve Stimulation (1980); Pain (1994)

Event Date 11/14/2022

Event Type  Injury  

Event Description

It was reported that the deep brain stimulation (dbs) clinical study patient experienced pain and tension along the lead for the first four days after having an implantable pulse (ipg) revision procedure (mfg.Report 3006630150-2022-07250).The event has since improved, however, when the patient laid her head down to sleep, the lead still generated stimulation, and the pain and tension remained.There were no sensorimotor deficits due to this event.The patient was hospitalized for one day and underwent a procedure in which the lead and ipg were revised.The devices remain implanted.No additional adverse patient effects were reported, and the event has resolved.

Manufacturer Narrative

Additional suspect medical device component involved in the event: brand name: vercise genus, upn: m365db12160, model: db-1216, serial: (b)(4), batch: 541153.

Manufacturer Narrative

Correction to initial mdr: box b5: there was no stimulation issue, rather the symptom was only pain and tension, box f10 patient code, box h6 patient code.Additional suspect medical device component involved in the event: brand name: vercise genus, upn: m365db12160, model: db-1216, serial: (b)(6), batch: (b)(6).

Event Description

It was reported that the deep brain stimulation (dbs) clinical study patient experienced pain and tension along the lead for the first four days after having an implantable pulse (ipg) revision procedure (mfg.Report 3006630150-2022-07250).The patient was hospitalized for one day and underwent a procedure in which the lead and ipg were revised.The devices remain implanted.No additional adverse patient effects were reported, and the event has resolved.

Manufacturer Narrative

Additional suspect medical device component involved in the event: brand name: vercise genus, upn: m365db12160, model: db-1216, serial: (b)(6), batch: (b)(6).

Event Description

It was reported that the deep brain stimulation (dbs) clinical study patient experienced pain and tension along the lead for the first four days after having an implantable pulse (ipg) revision procedure (mfg.Report 3006630150-2022-07250).The patient was hospitalized for one day and underwent a procedure in which the lead and ipg were revised.The devices remain implanted.No additional adverse patient effects were reported, and the event has resolved.Additional information was received that the patient underwent a second revision surgery on (b)(6) 2022 due to continued pain along the lead.During the revision the lead and ipg were revised.The devices remain implanted.The patient was hospitalized for one day.No additional adverse patient effects were reported, and the event has resolved.

• 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: 16629001
• MDR Text Key: 312147908
• Report Number: 3006630150-2023-01598
• 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,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date: 08/23/2023

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?: No
• Device Operator: Lay User/Patient
• Device Expiration Date: 12/20/2023
• Device Model Number: DB-2202-30
• Device Catalogue Number: DB-2202-30
• Device Lot Number: 7076175
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 03/08/2023
• Initial Date FDA Received: 03/28/2023
• Supplement Dates Manufacturer Received: 06/20/2023; 07/31/2023
• Supplement Dates FDA Received: 07/18/2023; 08/23/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 12/20/2021
• 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; Required Intervention
• Patient Sex: Female