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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ST. JUDE MEDICAL, INC.(CRM-SYLMAR) 5366, INTEGRITY DR, AB 20 73 559; IMPLANTABLE PACEMAKER PULSE GENERATOR
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ST. JUDE MEDICAL, INC.(CRM-SYLMAR) 5366, INTEGRITY DR, AB 20 73 559; IMPLANTABLE PACEMAKER PULSE GENERATOR Back to Search Results
Model Number 5366
Medical Device Problem Code Pacemaker Found in Back-Up Mode (1440)
Health Effect - Clinical Code No Known Impact Or Consequence To Patient (2692)
Date of Event 11/19/2018
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 the pulse generator was in backup vvi mode.The device was explanted.The patient had no consequences.
 
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Brand Name
5366, INTEGRITY DR, AB 20 73 559
Common Device Name
IMPLANTABLE PACEMAKER PULSE GENERATOR
Manufacturer (Section D)
ST. JUDE MEDICAL, INC.(CRM-SYLMAR)
15900 valley view court
sylmar CA 91342
MDR Report Key8126546
Report Number2017865-2018-18209
Device Sequence Number2166100
Product Code DXY
UDI-Device Identifier05414734006866
UDI-Public05414734006866
Combination Product (Y/N)N
Initial Reporter StateTX
Initial Reporter CountryUS
PMA/510(K) Number
P880086
Number of Events Summarized1
Summary Report (Y/N)N
Device Implanted Year2008
Device Explanted Year2018
Reporter Type Manufacturer
Report Source company representative,user f
Initial Reporter Occupation Physician
Type of Report Initial,Followup
Report Date (Section B) 02/04/2019
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 Date02/29/2008
Device Model Number5366
Device Lot Number0002221314
Was Device Available for Evaluation? No
Was the Report Sent to FDA? No
Initial Date Received by Manufacturer 11/19/2018
Supplement Date Received by Manufacturer01/25/2019
Initial Report FDA Received Date12/03/2018
Supplement Report FDA Received Date02/04/2019
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;
Patient Age84 YR
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