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 Problems Fatigue (1849); Undesired Nerve Stimulation (1980); Weakness (2145); Shaking/Tremors (2515); No Code Available (3191)

Event Date 03/28/2019

Event Type  Injury  

Event Description

A report was received that following a dbs implant procedure the patient was not feeling like himself, moving slowly, hunched over, and his eyelids looked droopy and puffy.The patient was reprogrammed and felt well initially.On (b)(6) 2019 he had difficulty walking and sleeping, leg weakness, right hand tremor, staring for long periods of time and feeling foggy.He was reprogrammed again on (b)(6) 2019 and initially felt well.The patient then received one week in-patient rehabilitation for a better assessment.He underwent physical therapy, speech therapy, occupational therapy and reprogramming for optimum efficacy without side effects.The patient stated he felt much better and no longer felt foggy.The physician assessed the event was device related.The physical therapist and occupational therapist assessed he was doing better and his gait looked good.

• 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 CLONMEL LIMITED; cashel road; clonmel ; EI
• Manufacturer Contact: talar tahmasian ; 25155 rye canyon loop; valencia, CA 91355 ; 6619494863
• MDR Report Key: 8605992
• MDR Text Key: 144925302
• Report Number: 3006630150-2019-02225
• 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: company representative,health
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 05/13/2019

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: 12/13/2020
• Device Model Number: DB-1200-S
• Device Catalogue Number: DB-1200-S
• Device Lot Number: 736517
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 05/01/2019
• Initial Date FDA Received: 05/13/2019
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 12/13/2018
• 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: 68 YR