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

Model Number 0155

Device Problems Defective Device (2588); No Apparent Adverse Event (3189)

Patient Problems Syncope (1610); Bone Fracture(s) (1870); Unspecified Infection (1930); Injury (2348); No Code Available (3191); Syncope/Fainting (4411); Insufficient Information (4580)

Event Date 08/01/2020

Event Type  Injury  

Manufacturer Narrative

(b)(4).

Event Description

It was reported that the patient contacted technical services (ts) stating there had been an issue with one of his leads causing him to experience syncope and break 13 to 14 bones.This also led to him being hospitalized for four months.The patient noted that on the way to the hospital four months earlier the lead shorted and caused his chest to feel like it was on fire he also stated he had an infection and the cardiac resynchronization therapy defibrillator (crt-d), left ventricular (lv) lead, right ventricular (rv) and another manufacturer's right atrial (ra) leads were explanted approximately one week ago.The local area sales representative was contacted for additional information.The field representative stated that no further information is available from the clinic beyond another manufacturer's device and leads were implanted.No additional adverse patient effects were reported.

Manufacturer Narrative

Patient code 3191 captures the reportable event of surgery.Upon receipt at our post market quality assurance laboratory it was noted that the lead was returned in two segments, severed at approximately 177 mm from the terminal end.Analysis was unable to confirm the infection with laboratory testing.It appeared that some of the segments may not have been returned.Visual inspection revealed stretched and deformed coils in multiple places.The proximal cable coil crimp had been pulled proximally and the shocking coil was stretched.Testing was completed to assess the returned portion of the lead's electrical performance.Measurements were within normal limits.Further visual inspection revealed calcification on both of the lead's shocking coils in a couple places.Insulation abrasion at approximately 100 to 100 mm from the tip of the lead that exposed the rate sense negative lumen was also observed.The polytetrafluoroethylene (ptfe) insulation on the rate sense negative lumen appeared to be intact, however only one side was visible.In this case, we believe the stress was the result of lead contact with another lead.It was noted that this portion of the lead would have been located within the patient's heart.

Event Description

It was reported that the patient contacted technical services (ts) stating there had been an issue with one of his leads causing him to experience syncope and break 13 to 14 bones.This also led to him being hospitalized for four months.The patient noted that on the way to the hospital four months earlier the the lead shorted and caused his chest to feel like it was on fire he also stated he had an infection and the cardiac resynchronization therapy defibrillator (crt-d), left ventricular (lv) lead, right ventricular (rv) and another manufacturer's right atrial (ra) leads were explanted approximately one week ago.The local area sales representative was contacted for additional information.The field representative stated that no further information is available from the clinic beyond another manufacturer's device and leads were implanted.No additional adverse patient effects were reported.

• Brand Name: ENDOTAK ENDURANCE EZ
• Type of Device: IMPLANTABLE LEAD
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; 4100 hamline avenue north; saint paul MN 55112
• MDR Report Key: 11182259
• MDR Text Key: 227201340
• Report Number: 2124215-2021-00623
• 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: consumer
• Type of Report: Initial,Followup
• Report Date: 04/06/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/15/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 12/14/2003
• Device Model Number: 0155
• Device Catalogue Number: 0155
• Device Lot Number: 350200
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/01/2020
• Date Manufacturer Received: 02/23/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Life Threatening; Other; Required Intervention
• Patient Age: 66 YR