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

Model Number	DB-1140-S
Medical Device Problem Code	Unexpected Therapeutic Results (1631)
Health Effect - Clinical Code	Inadequate Pain Relief (2388)
Date of Event	10/20/2021
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Additional suspect medical device components involved in the event: product family: dbs-extension, upn: m365nm3138550, model: nm-3138-55, serial: (b)(4), batch: 7070066 and 7070322.
Event or Problem Description
It was reported that the patient experienced inadequate stimulation causing his preexisting symptoms to return.Several reprogramming sessions of the device system were made but were not successful.The device database was analyzed, and no anomalies were noted.The patient underwent an ipg, implantable pulse generator, and lead extension replacement procedure.The patient was doing well post operatively.The devices will not be returned for device analysis as they were retained by the facility.
Event or Problem Description
It was reported that the patient experienced inadequate stimulation causing his preexisting symptoms to return.Several reprogramming sessions of the device system were made but were not successful.The device database was analyzed, and no anomalies were noted.The patient underwent an ipg, implantable pulse generator, and lead extension replacement procedure.The patient was doing well post operatively.The devices will not be returned for device analysis as they were retained by the facility.A computerized tomography scan was performed, and no anomalies were identified.
Additional Manufacturer Narrative
Additional suspect medical device components involved in the event: product family: dbs-extension; upn: m365nm3138550; model: nm-3138-55; serial: (b)(6) and (b)(6); batch: 7070066 and 7070322.

• Brand Name: VERCISE PC
• Common Device Name: 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; cashel road; clonmel ; EI
• Manufacturer Contact: talar tahmasian ; 25155 rye canyon loop; valencia, CA 91355 ; 6619494863
• MDR Report Key: 13146284
• Report Number: 3006630150-2021-07431
• Device Sequence Number: 4589303
• Product Code: NHL
• UDI-Device Identifier: 08714729984467
• UDI-Public: 08714729984467
• Combination Product (Y/N): N
• Initial Reporter State: NY
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2020
• Device Explanted Year: 2021
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 01/29/2022

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
• Operator of Device: Lay User/Patient
• Device Expiration Date: 02/16/2021
• Device Model Number: DB-1140-S
• Device Catalogue Number: DB-1140-S
• Device Lot Number: 631570
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 12/09/2021
• Supplement Date Received by Manufacturer: 01/07/2022
• Initial Report FDA Received Date: 01/03/2022
• Supplement Report FDA Received Date: 01/29/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 02/17/2019
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 45 YR
• Patient Sex: Male