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

Model Number DB-1200

Device Problem Unexpected Therapeutic Results (1631)

Patient Problems Neurological Deficit/Dysfunction (1982); Dizziness (2194); Shaking/Tremors (2515); No Code Available (3191); Movement Disorder (4412); Speech Disorder (4415)

Event Date 06/24/2019

Event Type  Injury  

Event Description

A report was received that the study patient, (b)(6) registry study, was dissatisfied with the therapy tremor suppression and side effects.The patient underwent two additional procedures to implant additional devices including ipg, leads, and extensions.

Event Description

A report was received that the study patient, a4010 dbs registry study, was dissatisfied with the therapy tremor suppression and side effects.The patient underwent two additional procedures to implant additional devices including ipg, leads, and extensions.Additional information was received that the patient symptoms included worsening dysarthia and gait disturbens additional information was received that the patient symptoms of worsening dysarthia and gait disturbens included the patient not being able to speak at all.The patient also needed to use a walker and experienced increased dizziness.On admission, the patient had a resting and postural tremor, more pronounced on the left side and slight bradykinesia on the left side.The device was deactivated and there was significant improvement of dysarthrophonia, gait pattern but a drastic increase of tremor in all four extremities.

Manufacturer Narrative

Correction to follow-up 2 mdr in field a3.

Event Description

A report was received that the study patient, (b)(6) dbs registry study, was dissatisfied with the therapy tremor suppression and side effects.The patient underwent two additional procedures to implant additional devices including ipg, leads, and extensions.

Event Description

A report was received that the study patient, a4010 dbs registry study, was dissatisfied with the therapy tremor suppression and side effects.The patient underwent two additional procedures to implant additional devices including ipg, leads, and extensions.

Event Description

A report was received that the study patient, a4010 dbs registry study, was dissatisfied with the therapy tremor suppression and side effects.The patient underwent two additional procedures to implant additional devices including ipg, leads, and extensions.

Manufacturer Narrative

Additional suspect medical device components involved in the event: model: db-2202-45 serial/lot: (b)(6).Description: dbs directional lead sterile kit 45cm.

Event Description

A report was received that the study patient, (b)(6) dbs registry study, was dissatisfied with the therapy tremor suppression and side effects.The patient underwent two additional procedures to implant additional devices including ipg, leads, and extensions.Additional information was received that the patient symptoms included worsening dysarthria and gait disturbens.

Event Description

A report was received that the study patient, a4010 dbs registry study, was dissatisfied with the therapy tremor suppression and side effects.The patient underwent two additional procedures to implant additional devices including ipg, leads, and extensions.Additional information was received that the patient symptoms included worsening dysarthia and gait disturbens additional information was received that the patient symptoms of worsening dysarthia and gait disturbens included the patient not being able to speak at all.The patient also needed to use a walker and experienced increased dizziness.On admission, the patient had a resting and postural tremor, more pronounced on the left side and slight bradykinesia on the left side.The device was deactivated and there was significant improvement of dysarthrophonia, gait pattern but a drastic increase of tremor in all four extremities.Additional information was received that the patient was initially hospitalized on (b)(6) 2019 and discharged on (b)(6) 2019.

Event Description

A report was received that the study patient, a4010 dbs registry study, was dissatisfied with the therapy tremor suppression and side effects.The patient underwent two additional procedures to implant additional devices including ipg, leads, and extensions.Additional information was received that the patient symptoms included worsening dysarthia and gait disturbens additional information was received that the patient symptoms of worsening dysarthia and gait disturbens included the patient not being able to speak at all.The patient also needed to use a walker and experienced increased dizziness.On admission, the patient had a resting and postural tremor, more pronounced on the left side and slight bradykinesia on the left side.The device was deactivated and there was significant improvement of dysarthrophonia, gait pattern but a drastic increase of tremor in all four extremities.Additional information was received that the patient was initially hospitalized on (b)(6)2019 and discharged on (b)(6) 2019.Additional information was received that the patient experienced a deterioration of tremor, gait and dysarthria which could not be resolved equally with therapy adjustment.

Event Description

A report was received that the study patient, a4010 dbs registry study, was dissatisfied with the therapy tremor suppression and side effects.The patient underwent two additional procedures to implant additional devices including ipg, leads, and extensions.Additional information was received that the patient symptoms included worsening dysarthia and gait disturbens.Additional information was received that the patient symptoms of worsening dysarthia and gait disturbens included the patient not being able to speak at all.The patient also needed to use a walker and experienced increased dizziness.On admission, the patient had a resting and postural tremor, more pronounced on the left side and slight bradykinesia on the left side.The device was deactivated and there was significant improvement of dysarthrophonia, gait pattern but a drastic increase of tremor in all four extremities.Additional information was received that the patient was initially hospitalized on (b)(6) 2019 and discharged on (b)(6) 2019.Additional information was received that the patient experienced a deterioration of tremor, gait and dysarthria which could not be resolved equally with therapy adjustment.Additional information was received that the patient had a considerable ataxic gait pattern and prior to discharge on (b)(6) 2019 the stimulation was adjusted until the worsening dysarthria was considered tolerable.

• Brand Name: VERCISE GEVIA
• Type of Device: STIMULATOR, ELECTRICAL, IMPLANTED, FOR PARKINSONIAN TREMOR
• Manufacturer (Section D): BOSTON SCIENTIFIC NEUROMODULATION; 25155 rye canyon loop; valencia CA 91355
• MDR Report Key: 9413957
• MDR Text Key: 169203721
• Report Number: 3006630150-2019-07081
• 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,Followup,Followup
• Report Date: 07/08/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/04/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 06/20/2019
• Device Model Number: DB-1200
• Device Catalogue Number: DB-1200
• Device Lot Number: 20787523
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 06/30/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention