MAUDE Adverse Event Report: VERCISE GEVIA; STIMULATOR, ELECTRICAL, IMPLANTED, FOR PARKINSONIAN TREMOR

Model Number DB-1200

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

Patient Problems Hypersensitivity/Allergic reaction (1907); Unspecified Infection (1930)

Event Date 04/30/2019

Event Type  Injury  

Manufacturer Narrative

Additional suspect medical device components involved in the event: product family: dbs-linear leads upn: (b)(4).Model: db-2201-30dc serial: (b)(4).Batch: 20484031.Product family: dbs-linear leads upn: (b)(4).Model: db-2201-30dc serial: (b)(4).Batch: 20484031.Product family: dbs-linear leads upn: (b)(4).Model: db-2201-30dc serial: (b)(4).Batch: 20484031.Product family: dbs-linear leads upn: (b)(4).Model: db-2201-30dc serial: (b)(4).Batch: 20484031.Product family: dbs-extension upn: (b)(4).Model: nm-3138-55 serial: (b)(4).Batch: 20935214.Product family: dbs-extension upn: (b)(4).Model: nm-3138-55 serial: (b)(4).Batch: 20935214.

Event Description

It was reported the patient had a suspected infection and underwent a revision procedure to replace all implanted devices.The patient was doing well post-operatively.No further information has been obtained despite good faith efforts.

Event Description

It was reported the patient had a suspected infection and underwent a revision procedure to replace all implanted devices.The patient was doing well post-operatively.No further information has been obtained despite good faith efforts.Additional information received reported the infection was located around the leads and lead extensions.The patient had tested positive for infection and did well post-operatively.The physician later assessed that the infection was secondary to a sensitivity reaction.

Manufacturer Narrative

Correction to the follow-up 1 mdr in block h6.

Event Description

It was reported the patient had a suspected infection and underwent a revision procedure to replace all implanted devices.The patient was doing well post-operatively.No further information has been obtained despite good faith efforts.Additional information received reported the infection was located around the leads and lead extensions.The patient had tested positive for infection and did well post-operatively.The physician later assessed that the infection was secondary to a sensitivity reaction.

• Brand Name: VERCISE GEVIA
• Type of Device: STIMULATOR, ELECTRICAL, IMPLANTED, FOR PARKINSONIAN TREMOR
• MDR Report Key: 12054804
• MDR Text Key: 258619886
• Report Number: 3006630150-2021-03179
• Device Sequence Number: 1
• Product Code: MHY
• Combination Product (y/n): N
• PMA/PMN Number: P150031
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup,Followup
• Report Date: 11/01/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/23/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Expiration Date: 07/19/2022
• Device Model Number: DB-1200
• Device Catalogue Number: DB-1200
• Device Lot Number: 21264937
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 10/14/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 10/17/2017
• 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: 60 YR