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

Model Number DB-1200-S

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

Patient Problems Bacterial Infection (1735); Hypersensitivity/Allergic reaction (1907); No Code Available (3191)

Event Date 12/03/2020

Event Type  Injury  

Manufacturer Narrative

(b)(4).

Event Description

It was reported that the patient had an allergic reaction and blood infection with fever.The patient was given iv antibiotics.Patient was doing fine.

• Brand Name: VERCISE GEVIA
• 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; cashel road; clonmel ; EI
• Manufacturer Contact: talar tahmasian ; 25155 rye canyon loop; valencia, CA 91355 ; 6619494863
• MDR Report Key: 11060956
• MDR Text Key: 223365247
• Report Number: 3006630150-2020-06354
• Device Sequence Number: 1
• Product Code: NHL
• UDI-Device Identifier: 08714729984443
• UDI-Public: 08714729984443
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 12/22/2020

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: 09/25/2021
• Device Model Number: DB-1200-S
• Device Catalogue Number: DB-1200-S
• Device Lot Number: 740386
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 12/03/2020
• Initial Date FDA Received: 12/22/2020
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 09/26/2019
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 72 YR