MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION TELIGEN; IMPLANTABLE PULSE GENERATOR, PACEMAKER (NON-CRT)

Model Number E102

Device Problems Defective Device (2588); Data Problem (3196)

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

Event Date 07/25/2023

Event Type  malfunction  

Manufacturer Narrative

Upon receipt in our post market quality assurance laboratory, visual inspection noted scratches on the case as well as a weakened header bond.X-ray examination was performed.The right ventricular (rv) lead tip and rv coil header wires were found to be fractured and right atrial (ra) lead coil cracked.Improvements have been made to the manufacturing process in order to strengthen the bond between the header and the device case.Longevity and battery tests showed a cell depletion pattern that was similar to other devices that depleted normally.This device is included in the subpectoral implant advisory population.

Event Description

It was reported that the health care professional (hcp) was unable to read data on this implantable cardioverter defibrillator (icd).Boston scientific technical services (ts) discussed that the device may have reached elective replacement indicator (eri).Subsequently, this device was explanted and replaced with a new icd.No adverse patient effects were reported.

• Brand Name: TELIGEN
• Type of Device: IMPLANTABLE PULSE GENERATOR, PACEMAKER (NON-CRT)
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; 4100 hamline avenue north; saint paul MN 55112
• Manufacturer (Section G): BOSTON SCIENTIFIC CORPORATION; cashel road; clonmel ; EI
• Manufacturer Contact: timothy degroot ; 4100 hamline avenue north; saint paul, MN 55112 ; 6515826168
• MDR Report Key: 18354797
• MDR Text Key: 330874501
• Report Number: 2124215-2023-72077
• Device Sequence Number: 1
• Product Code: LWP
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P960040/S155
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional
• Reporter Occupation: Other Health Care Professional
• Remedial Action: Notification
• Type of Report: Initial
• Report Date: 12/19/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 09/08/2010
• Device Model Number: E102
• Device Catalogue Number: E102
• Device Lot Number: 248058
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/02/2023
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 12/14/2023
• Initial Date FDA Received: 12/19/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 09/09/2009
• 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 Age: 70 YR
• Patient Sex: Male