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

Model Number DB-1140

Device Problems Premature Discharge of Battery (1057); Battery Problem (2885); Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 06/28/2022

Event Type  Injury  

Manufacturer Narrative

Phone number: (b)(6).

Event Description

It was reported that the patient, that is enrolled in the a4010 clinical study, underwent an ipg, implantable pulse generator, revision procedure in which the device was explanted and re-implanted due to ventilation problems.The patient and the event are recovering and resolving.

Manufacturer Narrative

E1: phone number: (b)(6).

Event Description

It was reported that the patient, that is enrolled in the (b)(4) clinical study, underwent an ipg, implantable pulse generator, revision procedure in which the device was explanted and re implanted due to ventilation problems.The patient and the event are recovering and resolving.It was additionally reported that the patient's ventilation problems are of a pulmonary origin and not device and or procedure and or stimulation related.The ipg was replaced due to premature battery depletion.The event resolved.The ipg will not be returned by the facility and no reason was provided despite several good faith effort requests.

Event Description

It was reported that the patient, that is enrolled in the (b)(6) clinical study, underwent an ipg, implantable pulse generator, revision procedure in which the device was explanted and re-implanted due to ventilation problems.The patient and the event are recovering and resolving.It was additionally reported that the patient's ventilation problems are of a pulmonary origin and not device and or procedure and or stimulation related.The ipg was replaced due to it having a "flat battery" as stated by the clinical site.The event resolved.The ipg will not be returned by the facility and no reason was provided despite several good faith effort requests.

Manufacturer Narrative

E1: phone number: (b)(6).

• Brand Name: VERCISE PC
• Type of Device: STIMULATOR, ELECTRICAL, IMPLANTED, FOR PARKINSONIAN TREMOR
• Manufacturer (Section D): BOSTON SCIENTIFIC NEUROMODULATION; 25155 rye canyon loop; valencia CA 91355
• Manufacturer (Section G): BOSTON SCIENTIFIC CORPORATION; cashel road; clonmel ; EI
• Manufacturer Contact: talar tahmasian ; 25155 rye canyon loop; valencia, CA 91355 ; 6619494863
• MDR Report Key: 15017576
• MDR Text Key: 295908496
• Report Number: 3006630150-2022-03474
• Device Sequence Number: 1
• Product Code: MHY
• Combination Product (y/n): N
• Reporter Country Code: GM
• PMA/PMN Number: P150031
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,Study,Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date: 10/05/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/14/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 09/02/2021
• Device Model Number: DB-1140
• Device Catalogue Number: DB-1140
• Device Lot Number: 632215
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 09/08/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 09/03/2019
• 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: 62 YR
• Patient Sex: Female