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

Model Number DB-1216

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

Patient Problems Abscess (1690); Hematoma (1884); Unspecified Infection (1930); Swelling/ Edema (4577)

Event Date 04/10/2023

Event Type  Injury  

Event Description

It was reported that the patient went to the emergency room (er) with swelling on the right side of her head at the lead and lead extension connection site.The patient reported feeling tightness on the right side of her neck.While in the er the patients' swelling at the lead and lead extension site developed into an abscess.Redness and swelling were also noted at the implantable pulse generator (ipg) and lead extension connection site on her chest.The following day the patient underwent a full system explant.The physician noted minimal signs of infection at the lead and burr hole cover site, lead and lead extension site, and the ipg site.The cause of the infection is unknown, however the physician noted that during the stage two implant of the ipg a hematoma developed at the ipg site which may have caused the infection.Cultures were take at the three infection sites, but the results are not available.The patient spent the night in the hospital and prescribed antibiotics, and has been discharged.Per the facility's policy the devices were not released, therefore not returned for analysis.

Manufacturer Narrative

Additional suspect medical device components involved in the event: product family: dbs-linear leads, upn: m365db220145dc0, model: db-2201-45-dc, serial: (b)(6), batch: 7073101 and 7073116.Product family: dbs-lead fixation, upn: m365db4600c0, model: db-4600c, serial: n/a, batch: 30042542.Product family: dbs-extension, upn: m365db3128950, model: db-3128-95, serial: (b)(6), batch: 5000563.

• Brand Name: VERCISE GENUS
• 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: erik sherburne ; 25155 rye canyon loop; valencia, CA 91355 ; 7632920920
• MDR Report Key: 16943210
• MDR Text Key: 315354312
• Report Number: 3006630150-2023-02780
• Device Sequence Number: 1
• Product Code: NHL
• UDI-Device Identifier: 08714729985044
• UDI-Public: 08714729985044
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 05/16/2023

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 Model Number: DB-1216
• Device Catalogue Number: DB-1216
• Device Lot Number: 560463
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 04/22/2023
• Initial Date FDA Received: 05/16/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 01/19/2023
• 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; Hospitalization
• Patient Age: 53 YR
• Patient Sex: Female