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

Model Number 330-801

Device Problems Device remains implanted (1526); Malfunction (2409)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 08/26/2014

Event Type  malfunction  

Event Description

Report of lead sensing anomaly undersensing.

Manufacturer Narrative

(b)(4).

• Brand Name: ACCUFIX
• Type of Device: PERM IMPL PACER ELECTRODE
• Manufacturer (Section D): TELECTRONICS PACING SYSTEMS; 14520 northwest 60th ave; miami lakes FL 33014
• Manufacturer (Section G): 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: 4235083
• MDR Text Key: 17692949
• Report Number: 1723248-2014-00017
• Device Sequence Number: 1
• Product Code: DTB
• Combination Product (y/n): N
• Reporter Country Code: AS
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional
• Reporter Occupation: Other
• 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?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Expiration Date: 01/01/1995
• Device Model Number: 330-801
• Device Catalogue Number: 0330801
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Device Age: 268 MO
• Event Location: Hospital
• Date Manufacturer Received: 09/03/2014
• 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
• Removal/Correction Number: Z-209/211/5
• Patient Sequence Number: 1
• Patient Outcome(s): Other