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

Model Number DB-9218-15

Device Problems High impedance (1291); Unexpected Therapeutic Results (1631)

Patient Problem Movement Disorder (4412)

Event Date 10/10/2022

Event Type  Injury  

Event Description

It was reported that the deep brain stimulation (dbs) clinical patient enrolled in clinical study a4010 developed moderate worsening of parkinson's symptoms on the left side.High impedances measurements were discovered on the dbs pocket adaptor.The patient was treated with medication and the device was reprogrammed.The event resolved (b)(6) 2022.This reported event has a causal relationship to stimulation and hardware.

Manufacturer Narrative

Correction to field b5 - correction to initial report, as the patient's moderate worsening of parkinson's symptoms were on the right side, not on the left side as originally reported.Update to field h6 impact codes.Additional suspect medical device components involved in the event: product family: scs-adapters, upn: m365sc9218150, model: sc-9218-15, serial: (b)(6), batch: (b)(6).

Event Description

It was reported that the deep brain stimulation (dbs) clinical patient enrolled in clinical study a4010 developed moderate worsening of parkinson's symptoms on the left side.High impedance measurements were discovered on the dbs pocket adaptor.The patient was treated with medication and the device was reprogrammed.The event resolved on (b)(6) 2022.This event was reported as a causal relationship to stimulation and hardware.Additional information was received on 21feb2023 indicating that the patient underwent a revision procedure where two dbs pocket adaptors were explanted and replaced.The patient was doing well post-operatively.

• Brand Name: VERCISE
• Type of Device: STIMULATOR, ELECTRICAL, IMPLANTED, FOR PARKINSONIAN TREMOR
• 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 sherburne ; 25155 rye canyon loop; valencia, CA 91355 ; 7632920920
• MDR Report Key: 15904862
• MDR Text Key: 304692966
• Report Number: 3006630150-2022-06700
• Device Sequence Number: 1
• Product Code: MHY
• UDI-Device Identifier: 08714729905196
• UDI-Public: 08714729905196
• Combination Product (y/n): N
• Reporter Country Code: HU
• 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
• Report Date: 03/07/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/02/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 01/24/2024
• Device Model Number: DB-9218-15
• Device Catalogue Number: DB-9218-15
• Device Lot Number: 7073563
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 02/21/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 01/24/2022
• 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