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

Model Number DB-3128-95B

Device Problem High impedance (1291)

Patient Problem Scar Tissue (2060)

Event Date 01/23/2023

Event Type  Injury  

Event Description

It was reported that during the second stage of the deep brain stimulation implant procedure, when the already implanted lead extension was to be connected to the ipg, this lead extension was found to have not been coiled behind the ear in a way that made it accessible during the first stage implant procedure.In addition, scar tissue built around the lead behind the ear in the time between surgeries.The physician reopened the lead incision to get to the lead and extensively manipulated the uncoiled lead.The lead extension was then tested and displayed high impedances.The physician replaced the longer lead extension with a new shorter lead extension.The patient was doing well postoperatively.

Manufacturer Narrative

The returned lead extension was analyzed and confirmed the event.High impedance readings were measured on contacts 1, 9, 10, and 11.Visual inspection revealed that the lead extension body revealed multiple burn marks with fractured cables at the burned section of the lead extension body.The burn marks appear to be due to electrocautery exposure.The ifu states electrocautery can transfer destructive current into the dbs leads and/or stimulator.Bipolar or monopolar electrocautery may be used, however, electrocautery probes must be kept a minimum of one inch away from the implanted device.Additionally, the instructions for use (ifu) product label states that fibrosis (thickened skin and scarring) around the lead extension including tightening, tethering, and bowstringing, is a known risk with the use of deep brain stimulation system.Therefore, based on all the available information, engineers confirmed the use of electrocautery, thus resulting in high impedances was likely due to an unintended user error.

Event Description

It was reported that during the second stage of the deep brain stimulation implant procedure, when the already implanted lead extension was to be connected to the ipg, this lead extension was found to have not been coiled behind the ear in a way that made it accessible during the first stage implant procedure.In addition, scar tissue built around the lead behind the ear in the time between surgeries.The physician reopened the lead incision to get to the lead and extensively manipulated the uncoiled lead.The lead extension was then tested and displayed high impedances.The physician replaced the longer lead extension with a new shorter lead extension.The patient was doing well postoperatively.

• Brand Name: NA
• 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: 16671358
• MDR Text Key: 312583830
• Report Number: 2124215-2023-15635
• Device Sequence Number: 1
• Product Code: NHL
• UDI-Device Identifier: 00191506023584
• UDI-Public: 00191506023584
• Combination Product (y/n): N
• Reporter Country Code: US
• 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: 04/28/2023

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: Health Professional
• Device Model Number: DB-3128-95B
• Device Catalogue Number: DB-3128-95B
• Device Lot Number: 5000084
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 03/13/2023
• Initial Date FDA Received: 04/04/2023
• Supplement Dates Manufacturer Received: 04/11/2023
• Supplement Dates FDA Received: 04/28/2023
• Was Device Evaluated by Manufacturer?: Yes
• 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: 70 YR
• Patient Sex: Male
• Patient Ethnicity: Non Hispanic
• Patient Race: Asian