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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ST. JUDE MEDICAL, INC.(CRM-SYLMAR) QUADRA ALLURE MP CRT-P IMPLANTABLE PACEMAKER PULSE GENERATOR

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ST. JUDE MEDICAL, INC.(CRM-SYLMAR) QUADRA ALLURE MP CRT-P IMPLANTABLE PACEMAKER PULSE GENERATOR Back to Search Results
Model Number PM3562
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problem Hematoma (1884)
Event Type  Injury  
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 Description
It was reported that following a recent implant, the patient's pacer pocket was swollen and bruised. It was noted that the patient was bleeding into his pacer pocket. The pocket was opened and the blood clot evacuated. The physician elected to explant the system and implant a vvi pacer via the right subclavian vein. The procedure was completed with no complications. The patient was stable intra-procedure and post procedure.
 
Manufacturer Narrative
Analysis was normal. No anomalies were found. Interrogation of the device revealed it was above eri and had not reached the elective replacement indicator (eri) when received. No issues other than cosmetic damage were noted.
 
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Brand NameQUADRA ALLURE MP CRT-P
Type of DeviceIMPLANTABLE PACEMAKER PULSE GENERATOR
Manufacturer (Section D)
ST. JUDE MEDICAL, INC.(CRM-SYLMAR)
15900 valley view court
sylmar CA 91342
Manufacturer (Section G)
ST. JUDE MEDICAL, INC.(CRM-SYLMAR)
15900 valley view court
sylmar CA 91342
Manufacturer Contact
elizabeth boltz
15900 valley view court
sylmar, CA 91342
MDR Report Key9716899
MDR Text Key179716382
Report Number2017865-2020-02119
Device Sequence Number1
Product Code NKE
UDI-Device Identifier05414734510097
UDI-Public05414734510097
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
P030035
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 03/25/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received02/17/2020
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Expiration Date05/31/2021
Device Model NumberPM3562
Device Catalogue NumberPM3562
Device Lot NumberA000090169
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer02/26/2020
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA? No
Event Location No Information
Date Manufacturer Received03/24/2020
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured11/21/2019
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: 02/17/2020 Patient Sequence Number: 1
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