MAUDE Adverse Event Report: ST. JUDE MEDICAL 7F BIPOLAR PACING DM RH SHRD

Model Number 401772

Device Problems Circuit Failure (1089); Material Integrity Problem (2978)

Patient Problem Cardiac Arrest (1762)

Event Date 03/13/2014

Event Type  Injury  

Event Description

The information provided to sjm indicated a 7f pacel bipolar pacing catheter was selected for use.The distal connector pin of the implanted lead broke, resulting in the patient experiencing cardiac arrest.Another lead was placed.

Manufacturer Narrative

The results of the investigation are inconclusive since the device was not returned for analysis.Our investigation was limited to the review of the device history record, which showed that each manufacturing and inspection operation was performed and indicated complete in accordance with sjm specifications and procedures.Based on the information received, the cause of the reported incident could not be conclusively determined.The pacel bipolar pacing catheter instructions for use (ifu) states that potential adverse effects may be associated with the pacel bipolar pacing catheter.These include arrhythmias, cardiac perforation, cardiac tamponade, and damage to vessel or valve structures.The pacel bipolar flow directed pacing catheter instructions for use (ifu) recommend a defibrillator and respiratory assist equipment and/or anti-arrhythmia drugs should be readily available in the event complications arise during catheter placement.

• Brand Name: 7F BIPOLAR PACING DM RH SHRD
• Type of Device: BIPOLAR PACING
• Manufacturer (Section D): ST. JUDE MEDICAL; minnetonka MN
• Manufacturer Contact: denise johnson, rn ; 5050 nathan lane n; plymouth, MN 55442 ; 6517565400
• MDR Report Key: 3987487
• MDR Text Key: 4636938
• Report Number: 2182269-2014-00036
• Device Sequence Number: 1
• Product Code: LDF
• Combination Product (y/n): N
• Reporter Country Code: FR
• PMA/PMN Number: K875059
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 06/25/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/25/2014
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 08/31/2014
• Device Model Number: 401772
• Device Lot Number: 3475333
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 06/25/2014
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 09/01/2011
• 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