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

Model Number DB-1110C

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

Patient Problems Undesired Nerve Stimulation (1980); Neurological Deficit/Dysfunction (1982); Seizures (2063); No Code Available (3191)

Event Date 10/22/2020

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: 18431966 and 18431966.

Event Description

It was reported that the patient experienced unpleasant sensations, undesired stimulation, while charging.The patient indicated that she felt unwell and was unable to continue charging.After one such episode while charging the patient went to the emergency room, and discharged the same day.It was indicated that it may have been a possible dystonic seizure.It is unknown if any intervention was provided during the hospitalization.The patient is doing well.

Event Description

It was reported that the patient experienced unpleasant sensations, undesired stimulation, while charging.The patient indicated that she felt unwell and was unable to continue charging.After one such episode while charging the patient went to the emergency room, and discharged the same day.It was indicated that it may have been a possible dystonic seizure.It is unknown if any intervention was provided during the hospitalization.The patient is doing well.

Manufacturer Narrative

Block h6 patient code 3191: no code available was used as there is no equivalent fda code for additional intervention.

• Brand Name: VERCISE
• 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: 10858630
• MDR Text Key: 216839656
• Report Number: 3006630150-2020-05623
• Device Sequence Number: 1
• Product Code: MHY
• UDI-Device Identifier: 08714729820758
• UDI-Public: 08714729820758
• 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
• Report Date: 01/04/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/18/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Expiration Date: 01/19/2018
• Device Model Number: DB-1110C
• Device Catalogue Number: DB-1110C
• Device Lot Number: 18774748
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 12/21/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 69 YR