MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION TELIGEN; IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD)

Model Number E102

Device Problems Incorrect, Inadequate or Imprecise Result or Readings (1535); Delayed Charge Time (2586)

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

Event Date 05/15/2022

Event Type  Injury  

Event Description

It was reported that this implantable cardioverter defibrillator (icd) had reached battery capacity depletion (bcd).Additionally, the icd had triggered code 1007 due to capacitor charge time exceeding limitations.The charge times were found to be greater than 45 seconds.Technical services discussed and recommended device replacement.This device was explanted and replaced.No additionally adverse patient effects were reported.

• Brand Name: TELIGEN
• Type of Device: IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD)
• 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: 14538303
• MDR Text Key: 293080764
• Report Number: 2124215-2022-18299
• 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: 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?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 07/28/2010
• Device Model Number: E102
• Device Catalogue Number: E102
• Device Lot Number: 245722
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 05/17/2022
• Initial Date FDA Received: 05/28/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 07/30/2009
• 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 Outcome(s): Required Intervention; Hospitalization
• Patient Age: 65 YR
• Patient Sex: Male