MAUDE Adverse Event Report: CARDINAL / COVIDIEN KENDALL DISPOSABLE LEAD SET; CABLE, ELECTRODE

Model Number 33136T

Device Problem Defective Device (2588)

Patient Problem Complete Heart Block (2627)

Event Date 07/30/2017

Event Type  malfunction  

Event Description

The disposable leads from kendall on a pt had a defect and it was showing a posterior hemi block, ekg was performed showing sinus rhythm with first degree block as per previous ekg done in er.Leads were changed and no harm was caused.Five lead dual connect disposable lead set.Date of use (b)(6) 2017.Diagnosis or reason for use: elevated hr 140 range.

• Brand Name: KENDALL DISPOSABLE LEAD SET
• Type of Device: CABLE, ELECTRODE
• Manufacturer (Section D): CARDINAL / COVIDIEN; 15 hampshire st.; mansfield MA 02048
• MDR Report Key: 6794088
• MDR Text Key: 82821489
• Report Number: MW5071569
• Device Sequence Number: 1
• Product Code: IKD
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date: 08/07/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/14/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 33136T
• Device Catalogue Number: 33136T
• Device Lot Number: 289267
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 08/07/2017
• Is the Reporter a Health Professional?: Yes
• Was Device Evaluated by Manufacturer?: No Information
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Age: 91 YR
• Patient Weight: 66