MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION TELIGEN; PACEMAKER

Model Number E102

Device Problems Signal Artifact/Noise (1036); High impedance (1291); Over-Sensing (1438); Pacing Problem (1439)

Patient Problems Syncope/Fainting (4411); Twiddlers Syndrome (4563)

Event Date 02/22/2022

Event Type  Injury  

Event Description

It was reported that the patient with this implantable cardioverter-defibrillator (icd) experienced syncope.The patient was brought to the hospital.Upon evaluation, it was noted noise, that was oversensed on the right ventricular (rv) lead and some episodes with inappropriate anti-tachycardia pacing (atp) were delivered.There is no pacing inhibition.Rv lead damage was suspected.Currently, the icd remains in service, however, the icd therapy being turned off.No additional adverse patient effects were reported.

Manufacturer Narrative

Additional information was added to the following fields to capture the explant of the device: b1: adverse event/product problem.B2: outcome attributed to adverse event.B5: describe event or problem field.

Event Description

It was reported that the patient with this implantable cardioverter-defibrillator (icd) experienced syncope.The patient was brought to the hospital.Upon evaluation, it was noted noise, that was oversensed on the right ventricular (rv) lead and some episodes with inappropriate anti-tachycardia pacing (atp) were delivered.There is no pacing inhibition.Rv lead damage was suspected.Currently, the icd remains in service, however, the physician opted to turn off icd therapy.The patient is wearing a life vest and awaiting an upgrade procedure to be performed at a later date.No additional adverse patient effects were reported.Additional information received indicated that an x-ray was performed and the rv lead was found to be fractured.Additionally, twiddler syndrome was also observed.Subsequently, underwent procedure, the rv lead was explanted and replaced.Currently, the icd remains in service.No additional adverse patient effects were reported.

Event Description

It was reported that the patient with this implantable cardioverter-defibrillator (icd) experienced syncope.The patient was brought to the hospital.Upon evaluation, it was noted noise, that was oversensed on the right ventricular (rv) lead and some episodes with inappropriate anti-tachycardia pacing (atp) were delivered.There is no pacing inhibition.Rv lead damage was suspected.Currently, the icd remains in service, however, the physician opted to turn off icd therapy.The patient is wearing a life vest and awaiting an upgrade procedure to be performed at a later date.No additional adverse patient effects were reported.Additional information received indicated that the rv lead exhibited out-of-range shock impedance measurements.An x-ray was performed and the rv lead was found to be fractured.Additionally, twiddler syndrome was also observed.Subsequently, underwent procedure, the rv lead was explanted and replaced.No additional adverse patient effects were reported.

• Brand Name: TELIGEN
• Type of Device: PACEMAKER
• 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: 14068193
• MDR Text Key: 289010416
• Report Number: 2124215-2022-09280
• 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: Physician
• Type of Report: Initial,Followup,Followup
• Report Date: 05/05/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/09/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 08/10/2011
• Device Model Number: E102
• Device Catalogue Number: E102
• Device Lot Number: 260486
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 03/23/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 08/13/2010
• 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): Required Intervention; Hospitalization
• Patient Age: 57 YR
• Patient Sex: Female