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

Model Number DB-1200-S

Device Problems Inappropriate/Inadequate Shock/Stimulation (1574); Migration (4003)

Patient Problems Pocket Erosion (2013); Discomfort (2330); Swelling/ Edema (4577)

Event Date 10/22/2021

Event Type  Injury  

Event Description

It was reported that the patient experienced erosion at the lateral edge of pocket, right side of the implantable pulse generator (ipg) site.An x-ray revealed that the ipg had rotated where the header block was now upside down, and the lead extension wire connection and port plug were facing lateral.It was assessed that the tissue had been compromised and there was swelling at the site.The patient reported that he felt a tightness at the extension site in the neck and that one day there was a release.The patient also reported that there was one incident of a shocking sensation that the patient felt at the pocket site.The patient was admitted and administered antibiotics.The patient underwent a surgical procedure to remove the ipg and lead extension.The patient has been discharged.

Manufacturer Narrative

Additional suspect medical device component involved in the event: product family: dbs-extension, upn: m365nm3138550, model: nm-3138-55, serial: (b)(4), batch: 7045602.

Manufacturer Narrative

The returned ipg was analyzed and monitored stimulation on an oscilloscope found the outputs were consistent and correct on all electrodes.Current leakage tests and residual gas analysis verified no loss of electric current into the surrounding tissue.The ipg passed all the required tests and revealed no anomalies.The returned lead extension was analyzed and a visual inspection found the extension was cleanly cut and the boot connector was not returned.No anomalies were identified on the lead aside from the clean-cut.The damage to the device is a result of a typical explant procedure, and it is not considered a failure.A labeling review found that the reported event is a known risk of implanting a pulse generator as part of a system.

Event Description

It was reported that the patient experienced erosion at the lateral edge of pocket, right side of the implantable pulse generator (ipg) site.An x-ray revealed that the ipg had rotated where the header block was now upside down, and the lead extension wire connection and port plug were facing lateral.It was assessed that the tissue had been compromised and there was swelling at the site.The patient reported that he felt a tightness at the extension site in the neck and that one day there was a release.The patient also reported that there was one incident of a shocking sensation that the patient felt at the pocket site.The patient was admitted and administered antibiotics.The patient underwent a surgical procedure to remove the ipg and lead extension.The patient has been discharged.

• 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: 12814648
• MDR Text Key: 280776158
• Report Number: 3006630150-2021-06452
• 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: Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 12/23/2021

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: 02/20/2021
• Device Model Number: DB-1200-S
• Device Catalogue Number: DB-1200-S
• Device Lot Number: 737638
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/01/2021
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 10/22/2021
• Initial Date FDA Received: 11/15/2021
• Supplement Dates Manufacturer Received: 12/07/2021
• Supplement Dates FDA Received: 12/23/2021
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 02/21/2019
• 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): Hospitalization; Required Intervention
• Patient Age: 55 YR
• Patient Sex: Male