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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ST. JUDE MEDICAL, INC.(CRM-SUNNYVALE) ANTHEM RF CRT-P IMPLANTABLE PACEMAKER PULSE GENERATOR

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ST. JUDE MEDICAL, INC.(CRM-SUNNYVALE) ANTHEM RF CRT-P IMPLANTABLE PACEMAKER PULSE GENERATOR Back to Search Results
Model Number PM3210
Device Problem Device Operates Differently Than Expected (2913)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 10/18/2016
Event Type  Injury  
Manufacturer Narrative
(b)(4).
 
Event Description
It was reported that through merlin. Net transmission, a diagnostic anomaly in battery longevity measurement was observed. The transmission shows a battery voltage of 2. 59v with eri in less than 3 months. Since the patient was pacemaker dependent, physician decided to explant and replace the device. The patient tolerated the procedure well. Patient¿s condition was fine.
 
Manufacturer Narrative
Analysis did not confirm the premature battery depletion. Based on device settings, a longevity calculation was performed and found to be within expected limits. The device was tested on the bench and no anomalies were found.
 
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Brand NameANTHEM RF CRT-P
Type of DeviceIMPLANTABLE PACEMAKER PULSE GENERATOR
Manufacturer (Section D)
ST. JUDE MEDICAL, INC.(CRM-SUNNYVALE)
645 almanor avenue
sunnyvale CA 94085
Manufacturer (Section G)
ST. JUDE MEDICAL, INC.(CRM-SUNNYVALE)
645 almanor avenue
sunnyvale CA 94085
Manufacturer Contact
denise johnson
5050 nathan lane north
plymouth, MN 55442
6517564470
MDR Report Key6231850
MDR Text Key64125198
Report Number2938836-2017-01538
Device Sequence Number1
Product Code NKE
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
P880086
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,health
Reporter Occupation
Type of Report Initial,Followup
Report Date 10/18/2016
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received01/07/2017
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date06/30/2011
Device Model NumberPM3210
Device Lot Number2891258
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer12/30/2016
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received02/23/2017
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured12/01/2009
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

Patient Treatment Data
Date Received: 01/07/2017 Patient Sequence Number: 1
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