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

Model Number 5826

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

Patient Problems Wound Dehiscence (1154); Hematoma (1884); Unspecified Infection (1930); Swelling (2091); Dizziness (2194)

Event Date 12/22/2020

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.Further information was requested but not received.

Event Description

Related manufacturer reference number: 2017865-2020-25228; 2017865-2020-25231.It was reported that a patient presented to the hospital on (b)(6) 2020 with dizziness and a pocket infection.The patient's pacemaker, atrial lead, and right ventricular lead were explanted on (b)(6) 2020.The patient was stable throughout.

Manufacturer Narrative

Additional information: b5, e1, e3, h6.

Event Description

New information noted that a replacement procedure for the pacemaker, atrial lead, and right ventricular lead occurred on (b)(6) 2020.The patient was also observed to have swelling, redness, hematoma, and wound dehiscence around the device pocket prior to the implantable cardioverter defibrillator system explant on (b)(6)2020.

Manufacturer Narrative

Analysis was normal.No anomalies were found.

• 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: 11098771
• MDR Text Key: 224511419
• Report Number: 2017865-2020-25226
• 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,Followup
• Report Date: 02/26/2021

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?: No
• Device Operator: Health Professional
• Device Expiration Date: 11/30/2021
• Device Model Number: 5826
• Device Catalogue Number: 5826
• Device Lot Number: P000103644
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/26/2021
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 12/26/2020
• Initial Date FDA Received: 12/30/2020
• Supplement Dates Manufacturer Received: 01/02/2021; 02/02/2021
• Supplement Dates FDA Received: 01/14/2021; 02/26/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: TENDRIL ST; TENDRIL ST; TENDRIL ST; TENDRIL ST
• Patient Outcome(s): Required Intervention