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

Model Number 330-854

Device Problem Explanted (1217)

Patient Problem Surgical procedure (2357)

Event Date 09/15/2014

Event Type  Injury  

Event Description

On (b)(6) 2014 received explanted lead from st jude medical.No explant information provided.Investigational letters will be sent to the implanting hospital and implanting physician with follow-up calls if required.

Manufacturer Narrative

• Brand Name: ENCOR
• Type of Device: PERM IMPL PACER ELECTRODE
• Manufacturer (Section D): TELECTRONICS PACING SYSTEMS, INC.; 14520 northwest 60th avenue; miami lakes FL 33014
• Manufacturer (Section G): TELECTRONICS PACING SYSTEMS, INC.; 14520 northwest 60th avenue; miami lakes FL 33014
• Manufacturer Contact: cindy hazen ; 17011 lincoln avenue; parker, CO 80134-8815 ; 3036458033
• MDR Report Key: 4223859
• MDR Text Key: 5076660
• Report Number: 1723248-2014-00018
• 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: 10/29/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/31/2014
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 12/07/1997
• Device Model Number: 330-854
• Device Catalogue Number: 0330854
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Device Age: 235 MO
• Event Location: Hospital
• Date Manufacturer Received: 10/28/2014
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 12/15/1994
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Removal/Correction Number: Z-1771/1772/5
• Patient Sequence Number: 1
• Patient Age: 79 YR