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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: TELECTRONICS PACING SYSTEMS ACCUFIX; PERM IMPL PACER ELECTRODE
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TELECTRONICS PACING SYSTEMS ACCUFIX; PERM IMPL PACER ELECTRODE Back to Search Results
Model Number 330-801
Device Problems Electrode(s), fracture of (1202); Migration or Expulsion of Device (1395); Device, or device fragments remain in patient (1527)
Patient Problems Chest Pain (1776); Cardiac Tamponade (2226); Surgical procedure (2357)
Event Date 01/28/2015
Event Type  Injury  
Event Description
Lead explant - j wire fractured and migrated causing cardiac tamponade and pericardial effusion.
 
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Brand Name
ACCUFIX
Type of Device
PERM IMPL PACER ELECTRODE
Manufacturer (Section D)
TELECTRONICS PACING SYSTEMS
14520 northwest 60th ave
miami lake FL 33014
Manufacturer (Section G)
TELECTRONICS PACING SYSTEMS, INC.
14520 northwest 60th avenue
miami lakes FL 33014
Manufacturer Contact
cindy hazen
17011 lincoln avenue
pmb 514
parker, CO 80134-8815
3036458033
MDR Report Key4541923
MDR Text Key5541401
Report Number1723248-2015-00001
Device Sequence Number1
Product Code DTB
Combination Product (y/n)N
Reporter Country CodeUS
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Health Professional
Reporter Occupation Physician
Remedial Action Recall
Type of Report Initial
Report Date 02/19/2015
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received02/20/2015
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator Health Professional
Device Model Number330-801
Device Catalogue Number0330801
Is the Reporter a Health Professional? Yes
Device Age248 MO
Event Location Hospital
Date Manufacturer Received02/04/2015
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured04/06/1994
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial
Removal/Correction NumberZ-209/211/5
Patient Sequence Number1
Patient Outcome(s) Hospitalization;
Patient Age45 YR
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