MAUDE Adverse Event Report: TELECTRONICS PACING SYSTEMS, INC. ENCOR; PERM IMPL PACER ELECTRODE

Model Number 327-752

Device Problem Explanted (1217)

Patient Problem Surgical procedure (2357)

Event Date 07/15/2014

Event Type  Injury  

Event Description

On (b)(6) 2014 received explanted lead from st jude medical.No explant info provided.Investigational letters will be sent to implanting physician and center.

• Brand Name: ENCOR
• Type of Device: PERM IMPL PACER ELECTRODE
• Manufacturer (Section D): TELECTRONICS PACING SYSTEMS, INC.; 14520 northwest 60th ave; miami lakes FL 33014
• Manufacturer Contact: cindy hazen ; 17011 lincoln ave; parker, CO 80134-8815 ; 3036458033
• MDR Report Key: 4107126
• MDR Text Key: 4836372
• Report Number: 1723248-2014-00013
• Device Sequence Number: 1
• Product Code: DTB
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional
• Reporter Occupation: No Information
• Remedial Action: Recall
• Type of Report: Initial
• Report Date: 09/03/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/05/2014
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Other
• Device Model Number: 327-752
• Device Catalogue Number: 0327752
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Device Age: 372 MO
• Event Location: Hospital
• Date Manufacturer Received: 09/02/2014
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Removal/Correction Number: Z-1771/1772/5
• Patient Sequence Number: 1
• Patient Outcome(s): Other