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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 PM2272
Device Problem Migration or Expulsion of Device (1395)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Type  malfunction  
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
Related manufacturer reference number: 2017865-2021-27094.Related manufacturer reference number: 2017865-2021-27095.It was reported a patient's right ventricular (rv) lead and atrial lead presented with dislodgement, confirmed by x-ray analysis.Both leads were no longer capturing.This was addressed by a procedure on (b)(6) 2021, in which it was discovered the anchor suture had snapped and caused the pacemaker to migrate.Both leads were explanted and replaced, while the pacemaker was revised and tied down with more sutures during the same procedure.Post-procedure the patient was stable.
 
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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 Key12250044
MDR Text Key264263706
Report Number2017865-2021-27093
Device Sequence Number1
Product Code LWP
UDI-Device Identifier05414734509589
UDI-Public05414734509589
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
P140033
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,health
Reporter Occupation Physician
Type of Report Initial
Report Date 07/29/2021
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 Date05/31/2022
Device Model NumberPM2272
Device Catalogue NumberPM2272
Device Lot NumberA000103202
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA? No
Initial Date Manufacturer Received 07/23/2021
Initial Date FDA Received07/29/2021
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured11/17/2020
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial
Patient Sequence Number1
Patient Age58 YR
Patient Weight167
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