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

Model Number 0145

Device Problems High impedance (1291); Pacing Problem (1439); Failure to Sense (1559); Material Integrity Problem (2978)

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

Event Date 06/02/2023

Event Type  Injury  

Manufacturer Narrative

If information is provided in the future, a supplemental report will be issued.

Event Description

It was reported that this right ventricular (rv) lead was showing within normal limits tests prior to implantable cardioverter defibrillator (icd) changeout.During the icd changeout, the physician used a scalpel to free old device.The physician complained about too much calcification.When the old rv lead was plugged to the new icd, there was no sensing and pacing, not even when using the pacing system analyzer.Also, shock lead impedance was high, out of range when using the new icd.It was assessed that the old lead may had been damaged during the cut down procedure.A new rv lead was implanted, and the old lead was surgically abandoned.No additional adverse patient effects were reported.

Manufacturer Narrative

If information is provided in the future, a supplemental report will be issued.

Event Description

It was reported that this right ventricular (rv) lead was showing within normal limits tests prior to implantable cardioverter defibrillator (icd) changeout.During the icd changeout, the physician used a scalpel to free old device.The physician complained about too much calcification.When the old rv lead was plugged to the new icd, there was no sensing and pacing, not even when using the pacing system analyzer.Also, shock lead impedance was high, out of range when using the new icd.It was assessed that the old lead may had been damaged during the cut down procedure.A new rv lead was implanted, and the old lead was surgically abandoned.No additional adverse patient effects were reported.

• Brand Name: ENDOTAK ENDURANCE RX
• Type of Device: IMPLANTABLE LEAD
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; 4100 hamline avenue north; saint paul MN 55112
• Manufacturer (Section G): BOSTON SCIENTIFIC CORPORATION; 4100 hamline avenue north; saint paul MN 55112 5798
• Manufacturer Contact: timothy degroot ; 4100 hamline avenue north; saint paul, MN 55112 ; 6515826168
• MDR Report Key: 17188756
• MDR Text Key: 317722489
• Report Number: 2124215-2023-32677
• Device Sequence Number: 1
• Product Code: LWS
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P910073/S025
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 08/07/2023

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: 09/17/2001
• Device Model Number: 0145
• Device Catalogue Number: 0145
• Device Lot Number: 309110
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 06/02/2023
• Initial Date FDA Received: 06/23/2023
• Supplement Dates Manufacturer Received: 07/17/2023
• Supplement Dates FDA Received: 08/07/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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): Hospitalization; Required Intervention
• Patient Age: 86 YR
• Patient Sex: Male