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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ST. JUDE MEDICAL, INC., CRMD MICRONY II SR PLUS; IMPLANTABLE PACEMAKER PULSE GENERATOR
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ST. JUDE MEDICAL, INC., CRMD MICRONY II SR PLUS; IMPLANTABLE PACEMAKER PULSE GENERATOR Back to Search Results
Model Number 2525T
Device Problem No Device Output (1435)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 11/04/2013
Event Type  Injury  
Event Description
It was reported that the pulse generator exhibited no output.The device was explanted and replaced.
 
Manufacturer Narrative
Analysis found normal device characteristics.
 
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Brand Name
MICRONY II SR PLUS
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 Key3566757
MDR Text Key4073227
Report Number2017865-2014-03819
Device Sequence Number1
Product Code DXY
Combination Product (y/n)N
Reporter Country CodeSA
PMA/PMN Number
NA
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
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Expiration Date05/31/2010
Device Model Number2525T
Device Catalogue NumberSMTFY999
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer12/03/2013
Is the Reporter a Health Professional? Yes
Distributor Facility Aware Date11/04/2013
Device Age66 MO
Event Location Hospital
Initial Date Manufacturer Received 11/18/2013
Initial Date FDA Received01/09/2014
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured05/09/2008
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial
Patient Sequence Number1
Patient Outcome(s) Required Intervention;
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