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

Model Number DB-2203-30C

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Emotional Changes (1831); Cramp(s) /Muscle Spasm(s) (4521)

Event Date 08/05/2022

Event Type  Injury  

Event Description

It was reported that the clinical study patient (a4092 cartesia extend 3d study) experienced a serious adverse event of acute change of nature, psychomotor agitation, and hyperkinesia which was due to accidental change in dbs program, with moderate severity.The patient was admitted to the hospital, medication was given and the device was reprogrammed.Stimulation was returned to the original program which showed significant improvement of psychomotor agitation, the stimulaiton was reduced to address the hyperkinesia.The patient showed clinical improvement and was discharged three days later.The event relationship to procedure and stimulation were reported as possible.The event resolved.

Manufacturer Narrative

Additional suspect medical device component involved in the event: product family: dbs-linear leads.Upn: m365db220330c0.Model: db-2203-30c.Serial: (b)(6).Batch: 5000410.

Manufacturer Narrative

E1: initial reporter phone: (b)(6).Additional suspect medical device component involved in the event: product family: dbs-linear leads, upn: m365db220330c0, model: db-2203-30c, serial: (b)(6), batch: (b)(6).

Event Description

It was reported that the clinical study patient (a4092 cartesia extend 3d study) experienced a serious adverse event of acute change of nature, psychomotor agitation, and hyperkinesia which was due to accidental change in dbs program, with moderate severity.The patient was admitted to the hospital, medication was given and the device was reprogrammed.Stimulation was returned to the original program which showed significant improvement of psychomotor agitation, the stimulation was reduced to address the hyperkinesia.The patient showed clinical improvement and was discharged three days later.The event relationship to procedure and stimulation were reported as possible.The event resolved.Additional information was provided that the event was not related to the procedure.

• 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: 15353495
• MDR Text Key: 331973293
• Report Number: 3006630150-2022-04512
• Device Sequence Number: 1
• Product Code: NHL
• Combination Product (y/n): N
• Reporter Country Code: GM
• 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: 03/09/2023

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?: No
• Device Operator: Lay User/Patient
• Device Expiration Date: 10/15/2022
• Device Model Number: DB-2203-30C
• Device Catalogue Number: DB-2203-30C
• Device Lot Number: 5000410
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 08/09/2022
• Initial Date FDA Received: 09/03/2022
• Supplement Dates Manufacturer Received: 09/13/2022; 02/14/2023
• Supplement Dates FDA Received: 10/07/2022; 03/09/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 10/15/2020
• 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
• Patient Age: 53 YR
• Patient Sex: Female