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

Model Number DB-2202-45

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

Patient Problems Muscle Weakness (1967); Undesired Nerve Stimulation (1980); Blurred Vision (2137); Loss of consciousness (2418); Diaphoresis (2452); Convulsion/Seizure (4406); Presyncope (4410); Syncope/Fainting (4411)

Event Date 07/21/2021

Event Type  Injury  

Event Description

It was reported the patient experienced a severe epileptic seizure.The patient was hospitalized and given antiepileptic therapy in the form of valproate, and stimulation was turned off.The patient has recovered, and the physician assessed the event as not related to the procedure, possibly related to stimulation, and unlikely related to the hardware.

Manufacturer Narrative

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

Event Description

It was reported the patient experienced a severe epileptic seizure.The patient was hospitalized and given antiepileptic therapy in the form of valproate, and stimulation was turned off.The patient has recovered, and the physician assessed the event as not related to the procedure, possibly related to stimulation, and unlikely related to the hardware.Additional information received stated the patient first experienced a pre-syncopal episode with blurred vision, sweating and intense asthenia.On the same day, the patient presented to the emergency room (er) and experienced a syncopal episode with a non-continuous feeling described as brain shocks.Later that day the patient experienced a generalized tonic-clonic seizure lasting approximately 30 seconds.After a postictal phase, the patient regained consciousness.

• 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
• MDR Report Key: 12285363
• MDR Text Key: 265350869
• Report Number: 3006630150-2021-04318
• Device Sequence Number: 1
• Product Code: NHL
• Combination Product (y/n): N
• PMA/PMN Number: P150031
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup
• Report Date: 08/18/2021

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: 04/26/2023
• Device Model Number: DB-2202-45
• Device Catalogue Number: DB-2202-45
• Device Lot Number: 7081564
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 07/26/2021
• Initial Date FDA Received: 08/05/2021
• Supplement Dates Manufacturer Received: 08/10/2021
• Supplement Dates FDA Received: 08/18/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention