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

Model Number 1888TC/52

Device Problems Structural Problem (2506); Device Contamination with Chemical or Other Material (2944)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 04/27/2016

Event Type  malfunction  

Manufacturer Narrative

(b)(4).

Event Description

It was reported that the patient presented to the operating room for device change out procedure due to normal eri.During procedure, the right atrial lead had blood in a cut.The physician attempted to squeeze the blood out in which insulation anomaly was noted.There were no electrical anomalies.The lead was repaired and remained implanted.The procedure was successfully concluded and the patient was in good condition.

• Brand Name: TENDRIL ST
• 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: jaime chavez ; 15900 valley view court; sylmar, CA 91342 ; 8184934022
• MDR Report Key: 5765817
• MDR Text Key: 48721536
• Report Number: 2017865-2016-04196
• Device Sequence Number: 1
• Product Code: NVN
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P960013
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 04/27/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 01/27/2010
• Device Model Number: 1888TC/52
• Device Lot Number: 0002130160
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 04/27/2016
• Initial Date FDA Received: 07/01/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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 Age: 67 YR