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

Model Number DB-1140

Device Problem Wireless Communication Problem (3283)

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

Event Date 12/26/2022

Event Type  Injury  

Event Description

It was reported that the patient underwent a deep brain stimulator lead replacement procedure (see mfg report 3006630150-2023-00884).After the leads were replaced and the physician connected the newly implanted leads to the implantable pulse generator (ipg) to check impedances.The physician linked the ipg with the remote control, but it could not measure impedances as he received communication failed message.After a couple of attempts and one hour later the ipg would not respond, and the ipg would not link at all.The patient underwent an ipg replacement procedure and after doing so, everything was working properly.The patient was doing fine post-operatively and is now experiencing major improvement in their treatment.

Manufacturer Narrative

Db-1140, serial (b)(6): the reported allegation of the ipg would not link to the remote control was confirmed.The ipg would not link to a known good remote control or clinical programmer, therefore no functional testing could be performed.Internal electrical measurements and thermal imaging confirmed that the application-specific integrated circuit, asic, is electrically shorted.This type of damage is typically caused by ipg exposure to magnetic resonance imaging, mri.The probable cause is unintended use error caused or contributed to event.

Event Description

It was reported that the patient underwent a deep brain stimulator lead replacement procedure (see mfg.Report 3006630150-2023-00884).After the leads were replaced and the physician connected the newly implanted leads to the implantable pulse generator (ipg) to check impedances.The physician linked the ipg with the remote control, but it could not measure impedances as he received communication failed message.After a couple of attempts and one hour later the ipg would not respond, and the ipg would not link at all.The patient underwent an ipg replacement procedure and after doing so, everything was working properly.The patient was doing fine post-operatively and is now experiencing major improvement in their treatment.

• 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: erik sherburne ; 25155 rye canyon loop; valencia, CA 91355 ; 7632920920
• MDR Report Key: 16453695
• MDR Text Key: 310357614
• Report Number: 3006630150-2023-00906
• Device Sequence Number: 1
• Product Code: MHY
• Combination Product (y/n): N
• Reporter Country Code: UP
• PMA/PMN Number: P150031
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,Health Professional,Company Representative,Distributor
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 06/08/2023

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: 07/13/2023
• Device Model Number: DB-1140
• Device Catalogue Number: DB-1140
• Device Lot Number: 633677
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 01/30/2023
• Initial Date FDA Received: 02/28/2023
• Supplement Dates Manufacturer Received: 05/19/2023
• Supplement Dates FDA Received: 06/08/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 07/13/2021
• 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: 39 YR
• Patient Sex: Female