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

Model Number 5820

Device Problem Data Problem (3196)

Patient Problem Fainting (1847)

Event Date 11/14/2018

Event Type  Injury  

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.

Event Description

It was reported patient experienced presyncope after the device tripped elective replacement indicator (eri).Upon interrogation, battery characteristics noted that the eri trip was likely premature eri.Clearing the eri as well as reprogramming the base rate to a higher setting was discussed.No further information available.

Event Description

New information available on feb 4, 2019 states that, the device was explanted and replaced with a competitive product in (b)(6) 2018.No further information was available.

Manufacturer Narrative

The reported event of premature elective replacement indicator was not confirmed in the laboratory.The device was tested, and no anomalies were found.

• Brand Name: ZEPHYR DR
• 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: robert greenleaf ; 15900 valley view court; sylmar, CA 91342 ; 8184932577
• MDR Report Key: 8118429
• MDR Text Key: 128863928
• Report Number: 2938836-2018-12596
• Device Sequence Number: 1
• Product Code: LWP
• UDI-Device Identifier: 05414734501613
• UDI-Public: 05414734501613
• 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: Nurse
• Type of Report: Initial,Followup,Followup
• Report Date: 06/04/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/29/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 04/30/2015
• Device Model Number: 5820
• Device Lot Number: 4307210
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/19/2019
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 05/21/2019
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 10/22/2013
• 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 Outcome(s): Required Intervention
• Patient Age: 81 YR
• Patient Weight: 79