MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION ENDOTAK ENDURANCE RX; IMPLANTABLE LEAD

Model Number 0144

Device Problems Signal Artifact/Noise (1036); Over-Sensing (1438)

Patient Problems Perforation of Vessels (2135); Vascular Dissection (3160); No Code Available (3191)

Event Date 06/25/2010

Event Type  Injury  

Manufacturer Narrative

No additional information is available.If additional information becomes available the report will be updated at that time.(b)(4).

Event Description

It was reported that there was oversensing of noise on the right ventricular (rv) lead and implantable cardioverter defibrillator (icd).The patient had an underlying rhythm thus no asystole occurred.Sensitivity was reprogrammed.The patient was referred to an electrophysiologist to determine further course of action.It was noted that just under five years later a revision procedure was performed and the lea was taken out of service.Over four and a half years later it was reported that this revision procedure occurred due to continued oversensing, including.T wave oversensing.It was further reported that when the physician attempted to remove the leads, he perforated and tore the svc.Emergent open heart surgery occurred and the lead was surgically abandoned.The lead was later explanted and once the patient healed from the open heart surgery an subcutaneous implantable cardioverter defibrillator (s-icd) system was implanted.No additional adverse patient effects were reported.

Event Description

This report is being filed to correct the device evaluated by manufacturer, method codes and additional mfr narrative fields that were inadvertently incorrect on the last report.

Manufacturer Narrative

The lead had previously been returned and analyzed.Upon receipt at our post market quality assurance laboratory visual inspection noted it was returned in two segments.The terminal segment was severed at 18 cm from the terminal pin.The second segment was the middle segment equaling 19 c in length.It was noted that the rate sense negative coils were missing.Calcium was noted on the distal shocking coil.The returned portions of the lead passed electrical testing.The field allegations of noise and oversensing were not able to be confirmed through testing of the returned portions of the lead.Patient code 3191 captures the additional intervention.This report is being filed to correct the h3 device evaluated by manufacturer, h6 method codes and h10 additional mfr narrative fields that were inadvertently incorrect on the last report.

• Brand Name: ENDOTAK ENDURANCE RX
• Type of Device: IMPLANTABLE LEAD
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; 4100 hamline avenue north; saint paul MN 55112
• MDR Report Key: 9965713
• MDR Text Key: 187867678
• Report Number: 2124215-2020-07471
• Device Sequence Number: 1
• Product Code: LWS
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative
• Type of Report: Initial,Followup
• Report Date: 10/28/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/15/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 12/06/2001
• Device Model Number: 0144
• Device Catalogue Number: 0144
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/12/2015
• Date Manufacturer Received: 09/22/2020
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Life Threatening; Required Intervention
• Patient Age: 37 YR