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

Model Number 5826

Device Problems High impedance (1291); Loose or Intermittent Connection (1371); Misconnection (1399); Capturing Problem (2891); High Capture Threshold (3266)

Patient Problems Dyspnea (1816); Discomfort (2330); Chest Tightness/Pressure (2463)

Event Date 10/28/2020

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 that the patient presented in clinic for a device follow-up.Upon interrogation it was determined that the ventricular lead exhibited high pacing impedance and increased capture threshold.The patient experienced chest tightness and shortness of breath.The physician decided to open the capsular bag on (b)(6) 2020 to investigate the pacemaker and lead.It revealed that the fixing set screw was slippery and could not be completely tightened and fixed.The pacemaker was explanted and replaced.The ventricular lead remained implanted.The patient was stable and discharged.

Manufacturer Narrative

Customer complaint of high pacing impedance, inadequate capture, loose or intermittent connection issue was not confirmed.Device was received in normal range of operation.Analysis of device was performed, including header evaluation, impedance test and output measurement, no anomaly was noted.Longevity assessment was performed, device was in normal range of operation with appropriate remaining longevity.

• Brand Name: ZEPHYR XL DR
• Type of Device: IMPLANTABLE PACEMAKER PULSE GENERATOR
• Manufacturer (Section D): ST. JUDE MEDICAL, INC.(CRM-SYLMAR); 15900 valley view court; sylmar CA 91342
• MDR Report Key: 10871238
• MDR Text Key: 217297738
• Report Number: 2017865-2020-17125
• Device Sequence Number: 1
• Product Code: NVZ
• UDI-Device Identifier: 05414734501620
• UDI-Public: 05414734501620
• Combination Product (y/n): N
• PMA/PMN Number: P880086
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup
• Report Date: 02/03/2021

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?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 05/31/2021
• Device Model Number: 5826
• Device Catalogue Number: 5826
• Device Lot Number: P000094137
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/24/2020
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 11/02/2020
• Initial Date FDA Received: 11/19/2020
• Supplement Dates Manufacturer Received: 01/28/2021
• Supplement Dates FDA Received: 02/03/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention