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

Model Number DB-1200-S

Device Problem Unexpected Therapeutic Results (1631)

Patient Problem No Code Available (3191)

Event Date 09/06/2019

Event Type  Injury  

Manufacturer Narrative

Additional suspect medical device components involved: product family: dbs-linear leads upn: (b)(4), model: sc-2202-45, serial: (b)(4), batch: 5137272.Product family: dbs-extension, upn: (b)(4), model: nm-3138-55, serial: (b)(4), batch: 7053779.The devices have not been returned for evaluation, therefore a failure analysis of the complaint devices could not be completed.A review of the devices history records will be conducted.If there is any further relevant information from that review, a supplemental med watch will be filed.

Event Description

A report was received that patient was not receiving adequate stimulation.The physician decided to schedule two separate appointments with the patient for reprogramming and troubleshooting.Post the reprogramming appointments patient still experienced inadequate stimulation and the physician decided to explant the ipg, right lead and extension, and replace them.Patient experienced a small brain bleed post operatively.He was subsequently discharged to an impatient rehabilitation hospital and is now home doing well.

Event Description

A report was received that patient was not receiving adequate stimulation.The physician decided to schedule two separate appointments with the patient for reprogramming and troubleshooting.Post the reprogramming appointments patient still experienced inadequate stimulation and the physician decided to explant the ipg, right lead and extension, and replace them.Patient experienced a small brain bleed post operatively.He was subsequently discharged to an impatient rehabilitation hospital and is now home doing well.

Manufacturer Narrative

The database analysis confirmed that the ipg was functioning properly.The returned ipg passed all test performed and revealed no anomalies.

• 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
• MDR Report Key: 9379696
• MDR Text Key: 168247784
• Report Number: 3006630150-2019-06830
• Device Sequence Number: 1
• Product Code: NHL
• UDI-Device Identifier: 08714729984443
• UDI-Public: 08714729984443
• 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,health
• Type of Report: Initial,Followup
• Report Date: 03/10/2020

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?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 05/07/2021
• Device Model Number: DB-1200-S
• Device Catalogue Number: DB-1200-S
• Device Lot Number: 738310
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/02/2019
• Initial Date Manufacturer Received: 11/01/2019
• Initial Date FDA Received: 11/26/2019
• Supplement Dates Manufacturer Received: 03/04/2020
• Supplement Dates FDA Received: 03/10/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 64 YR