MAUDE Adverse Event Report: ST. JUDE MEDICAL, INC., CRMD ACCENT DR RF; IMPLANTABLE PACEMAKER PULSE GENERATOR

Model Number PM2210

Device Problems Telemetry Discrepancy (1629); Capturing Problem (2891)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 01/04/2012

Event Type  malfunction  

Event Description

It was reported that at implant the pulse generator measured an atrial threshold of 1.25v at 0.5ms and the psa analyzer measured an atrial threshold of 1.2v at 0.5ms.The device was removed, and returned for analysis.

Manufacturer Narrative

All info provided by mfr, no medwatch form was received.This historical complaint is being filed as part of a retrospective review of complaint files in response to a recent fda inspection.There is no change to the actual performance of the product and this report only represents an enhancement to the reporting criteria going forward.Complaint could not be confirmed.All electrical and mechanical measurement were within standard device specifications.

• Brand Name: ACCENT DR RF
• Type of Device: IMPLANTABLE PACEMAKER PULSE GENERATOR
• Manufacturer (Section D): ST. JUDE MEDICAL, INC., CRMD; 15900 valley view ct.; sylmar CA 91342
• Manufacturer (Section G): ST. JUDE MEDICAL, INC., CRMD; 15900 valley view ct.; sylmar CA 91342
• Manufacturer Contact: cary lawler ; 15900 valley view ct.; sylmar, CA 91342 ; 8184932621
• MDR Report Key: 4077507
• MDR Text Key: 20457151
• Report Number: 2017865-2014-08005
• Device Sequence Number: 1
• Product Code: DXY
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: NA
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,User Facility
• Reporter Occupation: Physician
• Type of Report: Initial

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/14/2014
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 05/31/2013
• Device Model Number: PM2210
• Device Catalogue Number: SMTFY999
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 01/26/2012
• Is the Reporter a Health Professional?: Yes
• Distributor Facility Aware Date: 01/04/2012
• Device Age: 2 MO
• Event Location: Hospital
• Date Manufacturer Received: 01/06/2012
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 11/01/2011
• 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: 84 YR