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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 Telemetry Discrepancy (1629)
Patient Problem Twiddlers Syndrome (2114)
Event Date 12/01/2016
Event Type  malfunction  
Manufacturer Narrative
(b)(4).
 
Event Description
It was reported that the patient suffered from twiddler's syndrome. On (b)(6) 2016, the patient presented in clinic for normal device check. Upon interrogation, the left ventricular lead exhibited loss of capture. The lead was programmed off. On (b)(6) 2017, the patient presented for lead revision. Fluoroscopy was performed and revealed the lead was twisted due to twiddlers syndrome. During lead revision procedure, it was noted that the pulse generator exhibited intermittent telemetry. The lead was repositioned successfully. The device was explanted and replaced. The patient tolerated the procedure well and would continue to be followed normally.
 
Manufacturer Narrative
Analysis was normal. No anomalies were found.
 
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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
denise johnson
5050 nathan lane north
plymouth, MN 55442
6517564470
MDR Report Key6375043
MDR Text Key69160987
Report Number2017865-2017-01396
Device Sequence Number1
Product Code NKE
Combination Product (y/n)N
Reporter Country CodeUS
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 05/18/2017
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received03/02/2017
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date01/31/2018
Device Model NumberPM3262
Device Lot NumberA000025364
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer02/13/2017
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received04/26/2017
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured07/13/2016
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: 03/02/2017 Patient Sequence Number: 1
Treatment
(B)(4)
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