MAUDE Adverse Event Report: ST. JUDE MEDICAL, INC. ENDURITY MRI PACEMAKER, SR; IMPLANTABLE PACEMAKER PULSE GENERATOR

Model Number PM1172

Device Problem Programming Issue (3014)

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

Event Date 03/13/2018

Event Type  malfunction  

Event Description

Prior to device implant, the device could not be programmed.A new device was used for implantation and the patient was stable with no consequences.

Manufacturer Narrative

The device was in normal mode with patient data when received for analysis.Analysis performed including electrical, mechanical and environmental stress testing indicated the device exhibited normal characteristics.The device battery voltage is still near beginning of life (bol) level.Editing and programming patient data was performed and no anomaly was noted.The reported event of an inability to program the device was not confirmed.

• Brand Name: ENDURITY MRI PACEMAKER, SR
• Type of Device: IMPLANTABLE PACEMAKER PULSE GENERATOR
• Manufacturer (Section D): ST. JUDE MEDICAL, INC.; 15900 valley view court; sylmar CA 91342
• Manufacturer (Section G): ST. JUDE MEDICAL, INC.; 15900 valley view court; sylmar CA 91342
• Manufacturer Contact: robert greenleaf ; 15900 valley view court; sylmar, CA 91342 ; 8184932577
• MDR Report Key: 7408831
• MDR Text Key: 104875027
• Report Number: 2017865-2018-05430
• Device Sequence Number: 1
• Product Code: LWP
• Combination Product (y/n): N
• Reporter Country Code: FR
• PMA/PMN Number: P140033
• 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,Followup
• Report Date: 06/14/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/09/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 05/31/2019
• Device Model Number: PM1172
• Device Lot Number: A000048573
• Other Device ID Number: 05414734509596
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/05/2018
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 05/22/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 12/03/2017
• 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