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

Model Number E110

Device Problems Failure to Charge (1085); Incorrect, Inadequate or Imprecise Result or Readings (1535); Defibrillation/Stimulation Problem (1573)

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

Event Date 05/20/2022

Event Type  malfunction  

Event Description

It was reported that this implantable cardioverter defibrillator (icd) and right ventricular (rv) defibrillation lead resulted in a code 1004, indicative of a short circuit condition detected during shock delivery due to a low out-of-range shock impedance measurement less than 12.5 ohms.When the device attempted to charge again a code 1007 was recorded, indicative of a charge time exceeding 45 seconds.This icd system remains in service, however technical services (ts) recommended icd and rv lead replacement.No adverse patient effects were reported.

Manufacturer Narrative

The local area field representative was contacted for additional information.If information is provided in the future, a supplemental report will be issued.

• 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: 14538313
• MDR Text Key: 293339568
• Report Number: 2124215-2022-18593
• 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,Company Representative
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 05/28/2022

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: 06/02/2011
• Device Model Number: E110
• Device Catalogue Number: E110
• Device Lot Number: 147263
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 05/23/2022
• Initial Date FDA Received: 05/28/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 06/04/2010
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Age: 81 YR
• Patient Sex: Female