MAUDE Adverse Event Report: ST. JUDE MEDICAL, INC.(CRM-SYLMAR) 2525T MICRONY II, SR+, PKGD/STER; IMPLANTABLE PACEMAKER PULSE GENERATOR

Model Number 2525T

Device Problems Difficult to Interrogate (1331); Under-Sensing (1661)

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

Event Date 06/26/2016

Event Type  malfunction  

Manufacturer Narrative

(b)(4).

Event Description

It was reported that during a routine follow-up, the pulse generator exhibited undersensing and difficulty interrogating the device.The patient had recently suffered a fracture of the neck and femur the week before due to a fall.The fall was not related to the device.The patient was doing well although the patient is at the beginning stages of dementia.The physician elected to not perform a device revision.

• Brand Name: 2525T MICRONY II, SR+, PKGD/STER
• Type of Device: IMPLANTABLE PACEMAKER PULSE GENERATOR
• Manufacturer (Section D): ST. JUDE MEDICAL, INC.(CRM-SYLMAR); 15900 valley view court; sylmar CA 91342
• Manufacturer (Section G): ST. JUDE MEDICAL, INC.(CRM-SYLMAR); 15900 valley view court; sylmar CA 91342
• Manufacturer Contact: jaime chavez ; 15900 valley view court; sylmar, CA 91342 ; 8184934022
• MDR Report Key: 5826655
• MDR Text Key: 50581283
• Report Number: 2017865-2016-05012
• Device Sequence Number: 1
• Product Code: LWP
• Combination Product (y/n): N
• Reporter Country Code: GM
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 06/28/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/27/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 10/31/2013
• Device Model Number: 2525T
• Device Lot Number: 3515862
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 06/28/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 10/10/2011
• 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