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

Model Number D174

Device Problems High impedance (1291); Over-Sensing (1438); Pacing Problem (1439); Pocket Stimulation (1463)

Patient Problems Muscle Stimulation (1412); No Code Available (3191)

Event Date 07/25/2020

Event Type  Injury  

Manufacturer Narrative

(b)(4).If information is provided in the future, a supplemental report will be issued.

Event Description

It was reported that this implantable cardioverter defibrillator (icd) and right ventricular (rv) lead delivered inappropriate anti-tachycardia pacing (atp) due to noise on the rv lead.The patient reported to have received little electric shocks near the pocket.The patient was then admitted to the hospital and the device was deactivated.Device data review determined there was a clear indicator of a high impedance condition.The reported observations were suspected to be attributed to lead impairment.This device was deactivated, but currently remains implanted.No adverse patient effects were reported.

• Brand Name: AUTOGEN
• 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: 10781304
• MDR Text Key: 214436585
• Report Number: 2124215-2020-23384
• Device Sequence Number: 1
• Product Code: LWS
• Combination Product (y/n): N
• Reporter Country Code: UK
• 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: 11/03/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/03/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 11/17/2018
• Device Model Number: D174
• Device Catalogue Number: D174
• Device Lot Number: 214904
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 07/28/2020
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 12/06/2016
• 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; Required Intervention
• Patient Age: 48 YR