MAUDE Adverse Event Report: ST. JUDE MEDICAL, INC.(CRM-SYLMAR) QUADRA ALLURE MP CRT-P; IMPLANTABLE PACEMAKER PULSE GENERATOR

Model Number PM3562

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

Patient Problems Wound Dehiscence (1154); Purulent Discharge (1812); Unspecified Infection (1930); Pocket Erosion (2013)

Event Date 05/01/2020

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

Related manufacturer's number: 2017865-2020-06105.Related manufacturer's number: 2017865-2020-06106.Related manufacturer's number: 2017865-2020-06107.It was reported that the patient presented in the hospital with pacemaker pocket erosion and a possible sepsis/staph infection with wound dehiscence and serosanguinous drainage.There is no known allegation from a health professional that suggests the infection was related to the biventricular pacemaker system.The physician prophylactically explanted and replaced the pacemaker, right atrial lead, right ventricular lead, and left ventricular lead.The patient was in stable condition.

Manufacturer Narrative

As received, a pacemaker was returned above normal elective replacement indicator.No anomalies were found.

• Brand Name: QUADRA ALLURE MP CRT-P
• 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: 10080049
• MDR Text Key: 191732291
• Report Number: 2017865-2020-06103
• Device Sequence Number: 1
• Product Code: NKE
• UDI-Device Identifier: 05414734510097
• UDI-Public: 05414734510097
• Combination Product (y/n): N
• PMA/PMN Number: P030035
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Type of Report: Initial,Followup
• Report Date: 07/09/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/21/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 02/28/2021
• Device Model Number: PM3562
• Device Catalogue Number: PM3562
• Device Lot Number: A000085854
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/18/2020
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 07/09/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: QUARTET; TENDRIL STS; TENDRIL STS; QUARTET; TENDRIL STS; TENDRIL STS
• Patient Outcome(s): Other; Required Intervention
• Patient Age: 80 YR
• Patient Weight: 169