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

Model Number DB-2202-45

Device Problem Low impedance (2285)

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

Event Date 04/20/2023

Event Type  Injury  

Manufacturer Narrative

Additional suspect medical device components involved in the event: product family: dbs-extension, upn: (b)(4), model: nm-3138-55, serial: (b)(6), batch: 7058794.Product family: dbs-ipg-r-mri, upn: (b)(4), model: db-1200-s, serial: (b)(6), batch: 739156.

Event Description

It was reported that the patients deep brain stimulation (dbs) right lead exhibited low impedances.At the start of the case, it was unknown whether the issue was the lead, lead extension, or the implantable pulse generator (ipg).The patient underwent a revision procedure.The physician removed the existing lead from the extension and tested the lead by itself using the operation room (or) cable, which confirmed that the lead had low impedances.When the physician tried to remove the lead extension from the ipg site, the screw would not back out.The physician then cut the lead extension and removed the ipg.The lead extension was able to be pulled out of the ipg.The physician decided to replace the ipg and the lead.The physician decided to also explant the existing lead extension and tunnel two new extensions.The procedure went smoothly and was successful.The patient was doing well postoperatively.

Manufacturer Narrative

The returned lead db-2202-45, sn (b)(6) was analyzed and visual inspection revealed that the proximal array is bent/fractured between contacts 4 and 5.It appears that the lead became damaged during the proximal ends insertion into the lead extension.Crosstalk test confirmed that electrodes 3 and 5 are electrically shorted.The proximal array damage resulted in the reported complaint of low impedances.The returned ipg db-1200-s, sn (b)(6) was analyzed and visual inspection revealed that the septum on port c of the ipg was torn.After removing the septum from port c, it was observed that the setscrew had excessive foreign material.This would prevent the hex wrench from tightening or untightening the setscrew.The returned lead extension nm-3138-55, sn (b)(6) was analyzed and the reported event could not be confirmed with testing of the product return.However, visual inspection revealed that the lead was cleanly cut into two pieces approximately 5 cm from the proximal end of the lead.The clean-cut damage is a result of a typical explant procedure, and it is not considered a failure.Electrical test could not be performed due to the cut lead body.No other anomalies were identified on the returned portion of the lead.A labeling review of the lead was performed, and it did not reveal any anomalies as the instructions for use (ifu) states to take care not to bend or kink the proximal lead array, the stiff portion of the lead body adjacent to the array, or the lead extension connector during insertion.A labeling review of the ipg was performed and the ifu states that the torque wrench should be passed through the slit in the septum located on the side of the ipg header.Additionally, it states that the set screw should be tightened in the ipg header until the torque wrench clicks, indicating that the set screw is fully secured.The torque wrench is torque limiting so that the set screw cannot be overtightened.Only the wrench provided should be used, as other tools may overtighten the set screw and damage the lead extension.There is no evidence that the lead extension was used in a manner inconsistent with the labelled indications/ifu, therefore a labelling review was not performed.The reported event of low impedances and the set screw not backing out was confirmed through technical analysis of the lead and the ipg.It appears that the lead became damaged during the proximal ends insertion into the lead extension, and the proximal array damage resulted in the reported complaint of low impedances.Visual inspection of the ipg revealed that the septum on port c of the ipg was torn.After removing the septum from port c, it was observed that the set screw had excessive foreign material.This would prevent the hex wrench from tightening or untightening the set screw.Visual inspection of the lead extension revealed that the lead extension was cleanly cut into two pieces approximately 5 cm from the proximal end of the lead.No anomalies were identified on the lead extension aside from the clean-cut.The clean-cut damage to the lead extension is a result of a typical explant procedure and it is not considered a failure.The electrical test could not be performed due to the cut lead body.No other anomalies were identified on the returned portion of the lead aside from the clean-cut.The cause of the complaint is due to the associated ipg.

Event Description

It was reported that the patients deep brain stimulation (dbs) right lead exhibited low impedances.At the start of the case, it was unknown whether the issue was the lead, lead extension, or the implantable pulse generator (ipg).The patient underwent a revision procedure.The physician removed the existing lead from the extension and tested the lead by itself using the operation room (or) cable, which confirmed that the lead had low impedances.When the physician tried to remove the lead extension from the ipg site, the screw would not back out.The physician then cut the lead extension and removed the ipg.The lead extension was able to be pulled out of the ipg.The physician decided to replace the ipg and the lead.The physician decided to also explant the existing lead extension and tunnel two new extensions.The procedure went smoothly and was successful.The patient was doing well postoperatively.

• Brand Name: VERCISE CARTESIA
• 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: 16924140
• MDR Text Key: 315171601
• Report Number: 3006630150-2023-02719
• Device Sequence Number: 1
• Product Code: NHL
• UDI-Device Identifier: 08714729905288
• UDI-Public: 08714729905288
• 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: 06/16/2023

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: 05/15/2021
• Device Model Number: DB-2202-45
• Device Catalogue Number: DB-2202-45
• Device Lot Number: 7051198
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 04/20/2023
• Initial Date FDA Received: 05/12/2023
• Supplement Dates Manufacturer Received: 05/22/2023
• Supplement Dates FDA Received: 06/16/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 05/16/2019
• 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: 59 YR
• Patient Sex: Female