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

Model Number DB-3128-55B

Device Problems High impedance (1291); Defective Device (2588)

Patient Problem Paresthesia (4421)

Event Date 11/14/2023

Event Type  Injury  

Event Description

It was reported that the deep brain stimulation (dbs) patient experienced impedance issues.The patient underwent a revision procedure and the lead extension was found to be the issue.The wire was fraying near the bifurcation, so only the lead extension was replaced.The patient started to feel some tingling in his arm when he would press on the implantable pulse generator (ipg) site.The patient was doing well postoperatively and impedances are in range.

Manufacturer Narrative

Additional suspect medical device component involved in the event: product family: dbs-ipg-r-mri, upn: m365db12160, model: db-1216, serial: (b)(6), batch: 558442.A database analysis was performed for the vercise genus ipg and confirmed high impedances and an increase in the number of open circuits over time.There were no high impedances noted from the prior measurements but the database revealed 2 high impedance contacts in port l and 3 high impedance contacts in port l.High monopolar impedances may reflect a gap in connectivity indicating a possible break in the current path.The database cannot confirm the source or location of the observed high ohms or when the impedances went out of range.Program 2 possibly utilized a high impedance contact, as the log indicates more power usage during this time period when this program was used.Using programs that rely on high impedance contacts can require more power usage to maintain therapy and require more charging to avoid hibernation events.Also, therapy may not be delivered via electrode paths that measure high or out of range impedances; therefore, therapy may not be optimal when there are high impedance contact(s) used for programming.Since the ipg was not returned for analysis, the root cause of the high impedances could not be determined through the available logs.A return analysis is required to determine if device exhibits normal characteristics.Therefore, this investigation is unable to determine a probable cause for the complaint as the cause could not established.

Event Description

It was reported that the deep brain stimulation (dbs) patient experienced impedance issues.The patient underwent a revision procedure and the lead extension was found to be the issue.The wire was fraying near the bifurcation, so the lead extension was replaced.The patient started to feel some tingling in his arm when he would press on the implantable pulse generator (ipg) site.The patient was doing well postoperatively and impedances are in range.

Manufacturer Narrative

Additional suspect medical device component involved in the event: product family: dbs-ipg-r-mri.Upn: m365db12160.Model: db-1216.Serial: (b)(6).Batch: (b)(6).

• 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 CORPORATION; road 698, lot no. 12; dorado PR 00646 -260; * 00646-2602
• Manufacturer Contact: erik sherburne ; 25155 rye canyon loop; valencia, CA 91355 ; 7632920920
• MDR Report Key: 19056057
• MDR Text Key: 339552299
• Report Number: 3006630150-2024-02123
• Device Sequence Number: 1
• Product Code: NHL
• UDI-Device Identifier: 00191506023577
• UDI-Public: 00191506023577
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P150031
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 05/02/2024
• 2 Devices were Involved in the Event: 1 2

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 Model Number: DB-3128-55B
• Device Catalogue Number: DB-3128-55B
• Device Lot Number: 5000221
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 03/13/2024
• Initial Date FDA Received: 04/05/2024
• Supplement Dates Manufacturer Received: 04/08/2024
• Supplement Dates FDA Received: 05/02/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 10/20/2022
• 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: 49 YR
• Patient Sex: Male