MAUDE Adverse Event Report: TELECTRONICS PACING SYSTEMS, INC. ACCUFIX; PERM IMPL PACER ELECTRONIC

Model Number 330-801

Device Problems Explanted (1217); Insufficient Information (3190)

Patient Problem No Code Available (3191)

Event Date 05/19/2015

Event Type  Injury  

Manufacturer Narrative

Entire form filled out by manufacturer.

Event Description

Received report of explant from st.Jude.Under investigation to determine reason for explant and possible injury.

• Brand Name: ACCUFIX
• Type of Device: PERM IMPL PACER ELECTRONIC
• Manufacturer (Section D): TELECTRONICS PACING SYSTEMS, INC.; 14520 northwest 60th ave.; miami lakes FL 33014
• Manufacturer (Section G): TELECTRONICS PACING SYSTEMS; 14520 northwest 60th ave.; miami lakes FL 33014
• Manufacturer Contact: cindy hazen ; 17011 lincoln ave.; parker, CO 80134-8815 ; 3036458033
• MDR Report Key: 5006584
• MDR Text Key: 23983878
• Report Number: 1723248-2015-00005
• Device Sequence Number: 1
• Product Code: DXY
• 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
• Report Date: 08/12/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/12/2015
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 02/16/1997
• Device Model Number: 330-801
• Device Catalogue Number: 0330801
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Device Age: 254 MO
• Date Manufacturer Received: 07/13/2015
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 02/23/1994
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Removal/Correction Number: Z-209/211/5
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 66 YR