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

Model Number E102

Device Problems Use of Device Problem (1670); Material Integrity Problem (2978)

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

Event Date 06/21/2023

Event Type  malfunction  

Manufacturer Narrative

Upon receipt in our post market quality assurance laboratory, visual inspection confirmed the clinical observation of a weakened header bond.The header is slightly separated from the can.It appears that there is no adhesive on either the can or header.Improvements have been made to the manufacturing process in order to strengthen the bond between the header and the device case.

Event Description

It was reported that during a routine replacement procedure for normal battery depletion, the header of the device came loose during the explant.It was noted that the physician was not concerned and stated that he had applied excessive force to the header and expressed that he did not feel it was a device related issue, but rather his actions.No adverse patient effects were reported.It was noted that this device was not implanted in the sub pectoral position.This device was received for analysis.

• 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: 18231070
• MDR Text Key: 329280561
• Report Number: 2124215-2023-67544
• Device Sequence Number: 1
• Product Code: LWP
• Combination Product (y/n): N
• Reporter Country Code: AS
• PMA/PMN Number: P960040/S155
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 11/29/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/29/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 04/27/2010
• Device Model Number: E102
• Device Catalogue Number: E102
• Device Lot Number: 243040
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/07/2023
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 11/16/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 04/29/2009
• 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 Sex: Male