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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ST. JUDE MEDICAL, INC.(CRM-SYLMAR) ASSURITY MRI; IMPLANTABLE PACEMAKER PULSE GENERATOR

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ST. JUDE MEDICAL, INC.(CRM-SYLMAR) ASSURITY MRI; IMPLANTABLE PACEMAKER PULSE GENERATOR Back to Search Results
Model Number PM1272
Device Problem Migration or Expulsion of Device (1395)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 01/06/2022
Event Type  Injury  
Event Description
Related manufacturer reference number: 2017865-2022-01962.Related manufacturer reference number: 2017865-2022-01963.It was reported that the patient presented in clinic for a post implant check.Device interrogation revealed that the right ventricular lead had high capture thresholds and low sensing.A routine post-implant chest x-ray revealed that the pacemaker had dropped from its original position and caused the right ventricular lead to dislodge.On (b)(6) 2022, the lead was explanted and replaced.The pacemaker was re-implanted and a tyrex pouch was used and the pocket was closed.The patient was stable post procedure.
 
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Brand Name
ASSURITY MRI
Type of Device
IMPLANTABLE 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
sonali arangil
15900 valley view court
sylmar, CA 91342
MDR Report Key13361691
MDR Text Key284513357
Report Number2017865-2022-01962
Device Sequence Number1
Product Code LWP
UDI-Device Identifier05414734509572
UDI-Public05414734509572
Combination Product (y/n)N
Reporter Country CodeCA
PMA/PMN Number
P140033
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Foreign,Health Professional,User Facility,Company Representative
Reporter Occupation Physician
Type of Report Initial
Report Date 01/26/2022
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Expiration Date03/31/2023
Device Model NumberPM1272
Device Catalogue NumberPM1272
Device Lot NumberP000131096
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA? No
Initial Date Manufacturer Received 01/06/2022
Initial Date FDA Received01/26/2022
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured09/15/2021
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial
Patient Sequence Number1
Treatment
TENDRIL STS
Patient Outcome(s) Required Intervention;
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