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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ST. JUDE MEDICAL, INC.(CRM-SUNNYVALE) TENDRIL SDX LEAD; PERMANENT PACEMAKER ELECTRODE
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ST. JUDE MEDICAL, INC.(CRM-SUNNYVALE) TENDRIL SDX LEAD; PERMANENT PACEMAKER ELECTRODE Back to Search Results
Model Number 1688TC/40
Medical Device Problem Code Signal Artifact/Noise (1036)
Health Effect - Clinical Code No Known Impact Or Consequence To Patient (2692)
Date of Event 08/09/2019
Type of Reportable Event Serious Injury
Additional Manufacturer Narrative
The results of the investigation are inconclusive since the device was not returned for analysis.Based on the information received, the cause of the reported incident could not be conclusively determined.
 
Event or Problem Description
It was reported that atrial lead noise was noted on the stored electrocardiogram.The lead was capped and replaced on (b)(6) 2019.Patient's condition was stable before and after the procedure.
 
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Brand Name
TENDRIL SDX LEAD
Common Device Name
PERMANENT PACEMAKER ELECTRODE
Manufacturer (Section D)
ST. JUDE MEDICAL, INC.(CRM-SUNNYVALE)
645 almanor avenue
sunnyvale CA 94085
MDR Report Key8923152
Report Number2938836-2019-12269
Device Sequence Number2028481
Product Code NVN
UDI-Device Identifier05414734504812
UDI-Public05414734504812
Combination Product (Y/N)N
Initial Reporter StateCA
Initial Reporter CountryUS
PMA/510(K) Number
P960013
Number of Events Summarized1
Summary Report (Y/N)N
Device Implanted Year2010
Reporter Type Manufacturer
Report Source company representative,health
Initial Reporter Occupation Physician
Remedial Action Patient Monitoring
Type of Report Initial
Report Date (Section B) 08/22/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Operator of Device Health Professional
Device Expiration Date01/31/2011
Device Model Number1688TC/40
Device Lot Number0002122357
Was Device Available for Evaluation? No
Was the Report Sent to FDA? No
Type of Report(Section G)Thirty-Day
Initial Date Received by Manufacturer 08/09/2019
Initial Report FDA Received Date08/22/2019
Is This a Single-Use Device that was
Reprocessed and Reused on a Patient? (Y/N)		 No
Patient Sequence Number1
Outcome Attributed to Adverse Event Required Intervention;
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