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

Model Number PM2110

Device Problem Telemetry Discrepancy (1629)

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

Event Date 10/22/2013

Event Type  malfunction  

Event Description

It was reported that during the implant procedure, the pulse generator exhibited a magnet response anomaly when the leads were connected.The technician turned the magnet from battery test to off then back on, normal device function resumed.

Manufacturer Narrative

All information provided by manufacturer, no medwatch form was received.

• Brand Name: ACCENT DR
• Type of Device: IMPLANTABLE PACEMAKER PULSE GENERATOR
• Manufacturer (Section D): ST. JUDE MEDICAL, INC., CRMD; 15900 valley view court; sylmar CA 91342
• Manufacturer (Section G): ST. JUDE MEDICAL, INC., CRMD; 15900 valley view court; sylmar CA 91342
• Manufacturer Contact: cary lawler ; 15900 valley view court; sylmar, CA 91342 ; 8184932621
• MDR Report Key: 3563590
• MDR Text Key: 4077484
• Report Number: 2017865-2014-01665
• 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

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 02/28/2015
• Device Model Number: PM2110
• Device Catalogue Number: SMTFY999
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Distributor Facility Aware Date: 10/22/2013
• Device Age: 2 MO
• Event Location: Hospital
• Initial Date Manufacturer Received: 10/22/2013
• Initial Date FDA Received: 01/09/2014
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 08/27/2013
• 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: 81 YR