MAUDE Adverse Event Report: ST. JUDE MEDICAL, INC.(CRM-SYLMAR) ZEPHYR SR; IMPLANTABLE PACEMAKER PULSE GENERATOR

Model Number 5620

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Death (1802); Septic Shock (2068)

Event Date 07/07/2019

Event Type  Death  

Manufacturer Narrative

The results of the investigation are inconclusive since the device was not returned for analysis.Based on the information received, the cause of the reported incident could not be conclusively determined.Further information was requested but not received.The results/method and conclusion codes along with investigation results will be provided in the final report.

Event Description

Related manufacturer reference number: 2017865-2019-12503.It was reported that the patient deceased.There is no allegation from a healthcare professional that the death was device related.The cause of death was septic shock.No additional information was reported.

Manufacturer Narrative

Analysis was normal.No anomalies were found.

• Brand Name: ZEPHYR SR
• 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: elizabeth boltz ; 15900 valley view court; sylmar, CA 91342 ; 8184932577
• MDR Report Key: 8903999
• MDR Text Key: 154680209
• Report Number: 2017865-2019-12502
• Device Sequence Number: 1
• Product Code: LWP
• UDI-Device Identifier: 05414734501606
• UDI-Public: 05414734501606
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P880086
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,user faci
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 08/23/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 02/28/2013
• Device Model Number: 5620
• Device Lot Number: 3467903
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/02/2019
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 08/02/2019
• Initial Date FDA Received: 08/17/2019
• Supplement Dates Manufacturer Received: 08/23/2019
• Supplement Dates FDA Received: 08/23/2019
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 08/12/2011
• 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 Outcome(s): Death