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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: C.R. BARD, INC. (GFO) TEMPORARY PACING ELECTRODE; LDF
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C.R. BARD, INC. (GFO) TEMPORARY PACING ELECTRODE; LDF Back to Search Results
Catalog Number 007153P
Device Problem Device Operates Differently Than Expected (2913)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 11/30/2014
Event Type  malfunction  
Event Description
It was reported that once the device was placed inside the patient, it would not stimulate electrical impulses.They tried for three times and nothing happened.They then replaced the device for another of the same type and it worked fine.They used the same access and guidewire for the second device.
 
Manufacturer Narrative
Investigation is still in progress.Once the investigation is complete, a supplemental report will be filed.
 
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Brand Name
TEMPORARY PACING ELECTRODE
Type of Device
LDF
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 Key4377291
MDR Text Key5238942
Report Number1018233-2014-00367
Device Sequence Number1
Product Code LDF
Combination Product (y/n)N
PMA/PMN Number
K800298
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Health Professional
Reporter Occupation Other
Type of Report Initial
Report Date 12/02/2014
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received12/23/2014
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Catalogue Number007153P
Device Lot NumberGFYC0059
Was Device Available for Evaluation? Yes
Date Returned to Manufacturer12/16/2014
Is the Reporter a Health Professional? Yes
Date Manufacturer Received12/02/2014
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 Number1
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