MAUDE Adverse Event Report: ST. JUDE MEDICAL, INC.(CRM-SYLMAR) QUICKFLEX MICRO LV LEAD; PERMANENT PACEMAKER ELECTRODE

Model Number 1258T/75

Device Problems Fracture (1260); Appropriate Term/Code Not Available (3191)

Patient Problems Fatigue (1849); Low Blood Pressure/ Hypotension (1914)

Event Date 04/26/2018

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.(b)(4).

Event Description

It was reported that the patient began experiencing symptoms of fatigue in (b)(6) of 2018.The cause of patient symptoms was not verified.The patient was brought to the hospital on (b)(6) 2018 for an attempted pulse generator change but the procedure was not completed.On (b)(6) 2018, the left ventricular lead, right ventricular lead, and atrial lead exhibited signs of unspecified lead malfunction and lead fracture and were replaced.The implantable cardioverter defibrillator was also replaced.During the procedure, the patient experienced a transient episode of hypotension.Fluoroscopy imaging did not demonstrate significant pericardial effusion and heart borders remained of normal contour.The patient was hemodynamically stable throughout and post procedure.

• Brand Name: QUICKFLEX MICRO LV LEAD
• Type of Device: PERMANENT PACEMAKER ELECTRODE
• 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: robert greenleaf ; 15900 valley view court; sylmar, CA 91342 ; 8184932577
• MDR Report Key: 7936626
• MDR Text Key: 122789896
• Report Number: 2017865-2018-14861
• Device Sequence Number: 1
• Product Code: OJX
• UDI-Device Identifier: 05414734502603
• UDI-Public: 05414734502603
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P030054
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer,health professional
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 10/04/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/04/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 09/30/2014
• Device Model Number: 1258T/75
• Device Lot Number: 3500047
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 09/12/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 09/20/2011
• 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): Required Intervention