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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ST. JUDE MEDICAL, INC.(CRM-SYLMAR) ALLURE RF; IMPLANTABLE PACEMAKER PULSE GENERATOR
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ST. JUDE MEDICAL, INC.(CRM-SYLMAR) ALLURE RF; IMPLANTABLE PACEMAKER PULSE GENERATOR Back to Search Results
Model Number PM3222
Device Problem Pacemaker Found in Back-Up Mode (1440)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 05/06/2021
Event Type  malfunction  
Event Description
It was reported that during device preparation, the novel pacemaker was inappropriately in back-up operation.The pacemaker was not used.There was no patient involvement.
 
Manufacturer Narrative
The reported event of back-up operation was confirmed.Final analysis found that backup occurred due to error consistent with sensitivity to cold temperature.No other anomalies were found.
 
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Brand Name
ALLURE RF
Type of Device
IMPLANTABLE PACEMAKER PULSE GENERATOR
Manufacturer (Section D)
ST. JUDE MEDICAL, INC.(CRM-SYLMAR)
15900 valley view court
sylmar CA 91342
MDR Report Key11868671
MDR Text Key252143840
Report Number2017865-2021-18827
Device Sequence Number1
Product Code NIK
UDI-Device Identifier05414734507905
UDI-Public05414734507905
Combination Product (y/n)N
PMA/PMN Number
P030035
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,user f
Type of Report Initial,Followup
Report Date 06/08/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Expiration Date04/30/2022
Device Model NumberPM3222
Device Catalogue NumberPM3222
Device Lot NumberA000102341
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer05/10/2021
Was the Report Sent to FDA? No
Initial Date Manufacturer Received 05/06/2021
Initial Date FDA Received05/23/2021
Supplement Dates Manufacturer Received06/04/2021
Supplement Dates FDA Received06/08/2021
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
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