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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 RF CRT-P IMPLANTABLE PACEMAKER PULSE GENERATOR

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ST. JUDE MEDICAL, INC.(CRM-SYLMAR) QUADRA ALLURE MP RF CRT-P IMPLANTABLE PACEMAKER PULSE GENERATOR Back to Search Results
Model Number PM3262
Device Problem Positioning Problem (3009)
Patient Problems Low Blood Pressure/ Hypotension (1914); Unspecified Infection (1930); Low Oxygen Saturation (2477)
Event Date 07/16/2018
Event Type  Injury  
Manufacturer Narrative
No code available; due to saturated oxygen - a transesophageal echocardiography(tee)- was performed and based on what the surgeon saw he performed an emergency thoracotomy. 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 the patient developed an infection. The patient was dependent and a temporary pacing lead was implanted into the right ventricular apex. The system was explanted however the physician attempted multiple times to extract the right atrial lead ultimately had to use a cook locking stylet during which the patient's blood pressure and oxygen saturation dropped to very low levels. A transesophageal echocardiography(tee)- was performed and based on what the surgeon saw he performed an emergency thoracotomy. Upon opening up the chest cavity he noted blood and clots. He stopped the bleeding and transfused 5 units of blood. The right ventricular lead (b)(4) which had been capped and abandoned on (b)(6) 2017. The attempt was not successful the lead cut deep into the vein resulting in the lead retracting into the vein. The chest was closed and the patient was discharged to the cardiac icu.
 
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Brand NameQUADRA ALLURE MP RF 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
robert greenleaf
15900 valley view court
sylmar, CA 91342
8184932577
MDR Report Key7778037
MDR Text Key116936402
Report Number2017865-2018-11520
Device Sequence Number1
Product Code NKE
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
P910023
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,health
Reporter Occupation
Type of Report Initial
Report Date 08/13/2018
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received08/13/2018
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Expiration Date03/31/2018
Device Model NumberPM3262
Device Lot NumberA000028783
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA? No
Event Location No Information
Date Manufacturer Received07/16/2018
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured09/17/2016
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: 08/13/2018 Patient Sequence Number: 1
Treatment
1458Q/75, (B)(4) ; 1888TC/46, (B)(4) ; 2088TC/52, (B)(4)
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