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

Model Number 330-854

Device Problems Electrode(s), fracture of (1202); Device remains implanted (1526)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 11/12/2014

Event Type  malfunction  

Event Description

Rec'd device registration form indicating lead fractured and capped.

• Brand Name: ENCOR
• Type of Device: PERM IMPL PACER ELECTRODE
• Manufacturer (Section D): TELECTRONICS PACING SYSTEMS; 14520 nw 60th ave; miami lakes FL 33014
• Manufacturer (Section G): TELECTRONICS PACING SYSTEMS; 14520 nw 60th ave; miami lakes FL 33014
• Manufacturer Contact: cindy hazen ; 17011 lincoln ave; pmb 514; parker, CO 80134-8815 ; 3036458033
• MDR Report Key: 4727932
• MDR Text Key: 15973063
• Report Number: 1723248-2015-00003
• 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: Physician
• Remedial Action: Recall
• Type of Report: Initial
• Report Date: 04/10/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/17/2015
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 10/01/1993
• Device Model Number: 330-854
• Device Catalogue Number: 0330854
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Device Age: 286 MO
• Event Location: Hospital
• Date Manufacturer Received: 04/09/2015
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 12/21/1990
• 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
• Patient Age: 81 YR