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

Model Number E110

Device Problems Incorrect, Inadequate or Imprecise Result or Readings (1535); Delayed Charge Time (2586); Defective Device (2588); Data Problem (3196)

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

Event Date 06/06/2022

Event Type  Injury  

Manufacturer Narrative

If the product is returned, analysis would be performed and this report would be updated at that time.

Event Description

It was reported that this old implantable cardioverter defibrillator (icd) monitoring was disabled due to a limited battery capacity.Reportedly, this device recorded code 1007, message indicator that the shocking capacitors are not charged to the programmed voltage 45 seconds after the start of charging, which was preceded by an alert for low shock lead impedance detected when attempting to deliver a shock, caused by a lead fracture on the right ventricular (rv) lead.This icd got damaged after a tachy shock was delivered with low shock impedance.Thus, therapy was no longer guaranteed according to technical services.In addition, it appeared the device is corrupted as the explant indicator was displaying an incorrect date.Subsequently, both the icd and the rv lead were explanted and replaced.This icd is not expected to be returned for analysis and no additional adverse patient effects were reported.

Manufacturer Narrative

If the product is returned, analysis would be performed and this report would be updated at that time.Upon receipt at our post market quality assurance laboratory, visual inspection of the device identified no anomalies.A review of device memory found a charge time error code 1007 had been recorded.An x-ray of the device revealed that the internal high voltage fuse was damaged (i.E., no longer intact).This type of damage to the fuse most likely occurred during shock delivery into a low-resistance path (e.G.A shorted lead).The damage to the high voltage fuse prevented any subsequent charging of the high voltage capacitors and delivery of shock therapy, resulting in code 1007.This damage is deemed due to the environment outside of the device.However, the data issue allegation was not confirmed.No missing/corrupted data was found.

Event Description

It was reported that this old implantable cardioverter defibrillator (icd) monitoring was disabled due to a limited battery capacity.Reportedly, this device recorded code 1007, message indicator that the shocking capacitors are not charged to the programmed voltage 45 seconds after the start of charging, which was preceded by an alert for low shock lead impedance detected when attempting to deliver a shock, caused by a lead fracture on the right ventricular (rv) lead.This icd got damaged after a tachy shock was delivered with low shock impedance.Thus, therapy was no longer guaranteed according to technical services.In addition, it appeared the device is corrupted as the explant indicator was displaying an incorrect date.Subsequently, both the icd and the rv lead were explanted and replaced.This icd was returned for analysis and no additional 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: 14682695
• MDR Text Key: 293933699
• Report Number: 2124215-2022-20891
• 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: Other
• Type of Report: Initial,Followup
• Report Date: 05/18/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/13/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 11/19/2011
• Device Model Number: E110
• Device Catalogue Number: E110
• Device Lot Number: 158943
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 05/17/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 11/23/2010
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 85 YR
• Patient Sex: Male