MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION TELIGEN; IMPLANTABLE DEVICE

Model Number E102

Device Problems Failure to Convert Rhythm (1540); Inappropriate/Inadequate Shock/Stimulation (1574); Low impedance (2285)

Patient Problem Electric Shock (2554)

Event Date 10/16/2021

Event Type  Injury  

Event Description

It was reported that this patient with an implantable cardioverter defibrillator (icd) was inappropriately shocked for sinus tachycardia in which the rate accelerated into the ventricular fibrillation (vf) zone.Therapy was maxed in the ventricular tachycardia (vt) zone as the rate dropped back down.Shock polarity was programmed to reversed but was switched to initial for the last shock which resulted in a low out-of-range (oor) shock lead impedance measuring less than 20 ohms.Technical services recommended immediate device replacement as the patient may not be protected.Subsequently, the device was explanted and replaced and the right ventricular (rv) lead remains implanted.The lead was tested with a defibrillation threshold (dft) test after the implant in which it was successful.No additional adverse patient effects were reported.

• Brand Name: TELIGEN
• Type of Device: IMPLANTABLE DEVICE
• 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: 13262134
• MDR Text Key: 284112269
• Report Number: 2124215-2022-00835
• 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: Physician
• Type of Report: Initial
• Report Date: 01/14/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/14/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 06/16/2011
• Device Model Number: E102
• Device Catalogue Number: E102
• Device Lot Number: 258393
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 10/16/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 06/21/2010
• 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): Hospitalization; Other
• Patient Age: 65 YR
• Patient Sex: Male