MAUDE Adverse Event Report: BOSTON SCIENTIFIC NEUROMODULATION VERCISE GENUS R16 IMPLANTABLE PULSE GENERATOR KIT; STIMULATOR, ELECTRICAL, IMPLANTED, FOR PARKINSONIAN SYMPTOMS

Model Number DB-1216

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

Patient Problems Chest Pain (1776); Headache (1880); Unspecified Infection (1930); Pain (1994); Dizziness (2194); Fluid Discharge (2686)

Event Date 03/10/2021

Event Type  Injury  

Manufacturer Narrative

Additional suspect medical device component involved in the event: product family: dbs-linear leads, upn: (b)(4), model: db-2202-5, serial: (b)(4), batch: 7074285.

Event Description

It was reported that following a recent revision procedure, the patient experienced an infection at the ipg site and pain near the leads.The patient stated he had a headache and couldn't sleep because of a sharp pain toward the back, right next to where the 'glue' holds the extension to the leads.The patient was also suffering from high blood pressure and called his cardiologist, who told him to take a blood pressure pill.The patient felt lightheadedness, headache and dizziness but proceeded to sleep.When the patient woke up he noticed his shirt was wet just below his ipg incision site.The patient's wife placed gauze over his chest as instructed by the neurosurgeon and noticed yellow fluid on the gauze.That same afternoon the incision site was still draining and felt sore to the touch.The patient was seen by his physician on (b)(6) 2021, who placed a dressing over the infection site and told him to leave it on for 3 days.As of (b)(6) 2021, the patient stated the infection stopped draining and looked like it was healing.The infection was confirmed, but the cause of the infection was unknown.No cultures were taken and nothing was noted to have happened during the patient's recent revision procedure that could've caused the infection.The patient was also placed on antibiotics.

• Brand Name: VERCISE GENUS R16 IMPLANTABLE PULSE GENERATOR KIT
• 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: 11615085
• MDR Text Key: 243805484
• Report Number: 3006630150-2021-01402
• Device Sequence Number: 1
• Product Code: NHL
• UDI-Device Identifier: 08714729985044
• UDI-Public: 08714729985044
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P150031
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,consum
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 04/05/2021

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: 01/14/2023
• Device Model Number: DB-1216
• Device Catalogue Number: DB-1216
• Device Lot Number: 503286
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 03/11/2021
• Initial Date FDA Received: 04/05/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 01/14/2021
• 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
• Patient Age: 65 YR