MAUDE Adverse Event Report: ST. JUDE MEDICAL, INC.(CRM-SUNNYVALE) ASSURITY MRI; IMPLANTABLE PACEMAKER PULSE GENERATOR

Model Number PM1272

Device Problems Failure to Interrogate (1332); Missing Test Results (3267)

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

Event Date 02/20/2017

Event Type  malfunction  

Manufacturer Narrative

(b)(4).

Event Description

It was reported radio frequency communication was unavailable even with radio frequency capability.Multiple high ventricular rate episodes were stored, but the episodes could not be displayed.The patient has not been seen in the clinic since the last follow-up so the he issues have not been resolved.The patient condition is now stable.

• Brand Name: ASSURITY MRI
• 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: denise johnson ; 5050 nathan lane north; plymouth, MN 55442 ; 6517564470
• MDR Report Key: 6432700
• MDR Text Key: 71056582
• Report Number: 2938836-2017-19449
• Device Sequence Number: 1
• Product Code: LWP
• Combination Product (y/n): N
• Reporter Country Code: AS
• 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: 02/20/2017

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: 07/31/2017
• Device Model Number: PM1272
• Device Lot Number: P000022879
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 02/20/2017
• Initial Date FDA Received: 03/24/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 01/18/2016
• 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