MAUDE Adverse Event Report: ST. JUDE MEDICAL, INC.(CRM-SUNNYVALE) QUADRA ALLURE MP RF CRT-P; IMPLANTABLE PACEMAKER PULSE GENERATOR

Model Number PM3262

Device Problem Over-Sensing (1438)

Patient Problem Fainting (1847)

Event Date 10/25/2018

Event Type  Injury  

Event Description

It was reported that patient presented to the clinic for a device upgrade procedure.Prior to the procedure, upon device interrogation, oversensing far field r-waves was observed on the electrocardiogram channel.Device was checked on (b)(6) 2018 and a sustained ventricular tachycardia syncope episode was observed and programming changes were made.Patient was in atrial fibrillation and appropriate auto mode switch episodes were observed on the atrial channel; however, deflection was sensed on the atrial channel.Prior to the procedure, blunt dissection was used to remove some bulk scar tissue.Leads were checked under fluoroscopy and the ra lead was stable; however, the rv lead has lost slack and was chronic and old and therefore the rv lead was capped on (b)(6) 2018 and replaced.Device was explanted due to an upgrade procedure and a new device was implanted.New device interrogation showed no oversensing far field r-waves and upon fluoroscopy imaging leads were stable.Patient tolerated the procedure well and was stable.

Manufacturer Narrative

The reported event of over sensing and far field behavior was not confirmed in the laboratory.Analysis was normal.No anomalies were found.

• Brand Name: QUADRA ALLURE MP RF CRT-P
• Type of Device: IMPLANTABLE PACEMAKER PULSE GENERATOR
• Manufacturer (Section D): ST. JUDE MEDICAL, INC.(CRM-SUNNYVALE); 645 almanor avenue; sunnyvale CA 94085
• Manufacturer (Section G): ST. JUDE MEDICAL, INC.(CRM-SUNNYVALE); 645 almanor avenue; sunnyvale CA 94085
• Manufacturer Contact: robert greenleaf ; 15900 valley view court; sylmar, CA 91342 ; 8184932577
• MDR Report Key: 8052819
• MDR Text Key: 126596823
• Report Number: 2938836-2018-12085
• Device Sequence Number: 1
• Product Code: NKE
• UDI-Device Identifier: 05414734509091
• UDI-Public: 05414734509091
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P910023
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 12/21/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/08/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 05/31/2019
• Device Model Number: PM3262
• Device Lot Number: A000047736
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/05/2018
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 12/17/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 11/11/2017
• 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
• Patient Age: 83 YR
• Patient Weight: 54