MAUDE Adverse Event Report: C.R. BARD, INC. (GFO) TEMPORARY PACING ELECTRODE

Catalog Number 008556P

Device Problems Electrical /Electronic Property Problem (1198); Device Operates Differently Than Expected (2913)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 12/14/2014

Event Type  malfunction  

Event Description

It was reported that the electrode did not produce electrical currents when pretested.

Manufacturer Narrative

The investigation is still in progress.Once the investigation is complete a supplemental report will be filed.

• Brand Name: TEMPORARY PACING ELECTRODE
• Manufacturer (Section D): C.R. BARD, INC. (GFO); queensbury NY
• Manufacturer (Section G): C.R. BARD, INC. (GFO); 289 bay rd.; queensbury NY 12804 204
• Manufacturer Contact: christy lewis ; 8195 industrial blvd.; covington, GA 30014 ; 7707846100
• MDR Report Key: 4602595
• MDR Text Key: 5469160
• Report Number: 1018233-2015-00070
• Device Sequence Number: 1
• Product Code: LDF
• Combination Product (y/n): N
• Reporter Country Code: CH
• PMA/PMN Number: K800298
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Company Representative
• Reporter Occupation: Other
• Remedial Action: Other
• Type of Report: Initial
• Report Date: 02/11/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/06/2015
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 008556P
• Device Lot Number: GFXJ1698
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 02/27/2015
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 02/11/2015
• Was Device Evaluated by Manufacturer?: No
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1