MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION FLEXTEND; PERMANENT PACEMAKER ELECTRODE

Model Number 4087

Device Problems Over-Sensing (1438); Connection Problem (2900); Device Sensing Problem (2917)

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

Event Date 05/16/2023

Event Type  malfunction  

Manufacturer Narrative

If pertinent information is provided in the future, a supplemental report will be submitted.

Event Description

It was reported that echocardiogram (ekg) review of this pacemaker system appeared irregular.The pacemaker was pacing on the qrs, and not capturing.Upon further review via a 12-lead ekg, atrial fibrillation (af) undersensing was observed on the right ventricular (rv) lead channel, and rv signals were oversensed on the right atrial (ra) lead channel.The patient had a history of chronic atrial fibrillation (af) with a controlled ventricular response and usually paced 3-4% in the rv.It was determined that the rv and ra leads were reversed in the header.Technical services (ts) reviewed troubleshooting options and programming considerations, and the pacemaker system was reprogrammed to aair.This pacemaker system remains in service.No adverse patient effects were reported.

Event Description

It was reported that echocardiogram (ekg) review of this pacemaker system appeared irregular.The pacemaker was pacing on the qrs, and not capturing.Upon further review via a 12-lead ekg, atrial fibrillation (af) undersensing was observed on the right ventricular (rv) lead channel, and rv signals were oversensed on the right atrial (ra) lead channel.The patient had a history of chronic atrial fibrillation (af) with a controlled ventricular response and usually paced 3-4% in the rv.It was determined that the rv and ra leads were reversed in the header.Technical services (ts) reviewed troubleshooting options and programming considerations, and the pacemaker system was reprogrammed to aair.This pacemaker system remains in service.No adverse patient effects were reported.

Manufacturer Narrative

If pertinent information is provided in the future, a supplemental report will be submitted.

• Brand Name: FLEXTEND
• Type of Device: PERMANENT PACEMAKER ELECTRODE
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; 4100 hamline avenue north; saint paul MN 55112
• Manufacturer (Section G): CPI - DEL CARIBE; guidant puerto rico b. v.; #12, rd. #698; dorado PR 00646
• Manufacturer Contact: timothy degroot ; 4100 hamline avenue north; saint paul, MN 55112 ; 6515826168
• MDR Report Key: 18635103
• MDR Text Key: 334787090
• Report Number: 2124215-2024-06032
• Device Sequence Number: 1
• Product Code: DTB
• UDI-Device Identifier: 00802526397738
• UDI-Public: 00802526397738
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P960006/S005
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional
• Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date: 03/21/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/02/2024
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 04/11/2008
• Device Model Number: 4087
• Device Catalogue Number: 4087
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 02/27/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 04/11/2006
• 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 Age: 89 YR
• Patient Sex: Male