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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ST. JUDE MEDICAL, INC., CRMD ZEPHYR XL SR; IMPLANTABLE PACEMAKER PULSE GENERATOR
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ST. JUDE MEDICAL, INC., CRMD ZEPHYR XL SR; IMPLANTABLE PACEMAKER PULSE GENERATOR Back to Search Results
Model Number 5626
Device Problem No Device Output (1435)
Patient Problem Bradycardia (1751)
Event Date 10/10/2013
Event Type  Injury  
Event Description
It was reported that the patient presented to the hospital with an intrinsic pulse value of 30 - 40 beats per minute.The device was explanted and replaced.
 
Manufacturer Narrative
All information provided by manufacturer, no medwatch form was received.Analysis was normal.
 
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Brand Name
ZEPHYR XL SR
Type of Device
IMPLANTABLE PACEMAKER PULSE GENERATOR
Manufacturer (Section D)
ST. JUDE MEDICAL, INC., CRMD
15900 valley view court
sylmar CA 91342
Manufacturer (Section G)
ST. JUDE MEDICAL, INC., CRMD
15900 valley view court
sylmar CA 91342
Manufacturer Contact
cary lawler
15900 valley view court
sylmar, CA 91342
8184932621
MDR Report Key3548431
MDR Text Key4098467
Report Number2017865-2014-00102
Device Sequence Number1
Product Code DXY
Combination Product (y/n)N
PMA/PMN Number
P880086
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Foreign,Health Professional,User Facility
Reporter Occupation Physician
Type of Report Initial
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received01/02/2014
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator Health Professional
Device Expiration Date05/31/2011
Device Model Number5626
Device Catalogue NumberSMTFY999
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer10/28/2013
Is the Reporter a Health Professional? Yes
Distributor Facility Aware Date10/10/2013
Device Age47 YR
Event Location Hospital
Date Manufacturer Received10/10/2013
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured11/05/2009
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial
Patient Sequence Number1
Treatment
(B)(4)
Patient Outcome(s) Required Intervention;
Patient Age78 YR
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