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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 Problems Migration or Expulsion of Device (1395); Adverse Event Without Identified Device or Use Problem (2993)
Patient Problems Erosion (1750); Unspecified Infection (1930)
Event Date 07/20/2021
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
Related manufacturer reference number: 2017865-2021-26467, 2017865-2021-26468.It was reported that a patient presented on (b)(6) 2021 with their pacemaker outside of their body.An infection was also discovered.The patient's whole system, including their pacemaker, right atrial lead, and right ventricular lead were explanted and the pacemaker was replaced with a leadless pacemaker.The patient was recovering post procedure.
 
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.
 
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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
MDR Report Key12274076
MDR Text Key264955273
Report Number2017865-2021-26466
Device Sequence Number1
Product Code LWP
UDI-Device Identifier05414734509589
UDI-Public05414734509589
Combination Product (y/n)N
PMA/PMN Number
P140033
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,health
Type of Report Initial,Followup
Report Date 08/31/2021
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 Date07/31/2020
Device Model NumberPM2272
Device Catalogue NumberPM2272
Device Lot NumberA000072029
Was Device Available for Evaluation? No
Was the Report Sent to FDA? No
Initial Date Manufacturer Received 07/20/2021
Initial Date FDA Received08/04/2021
Supplement Dates Manufacturer Received08/31/2021
Supplement Dates FDA Received08/31/2021
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Treatment
TENDRIL STS; TENDRIL STS; TENDRIL STS; TENDRIL STS
Patient Outcome(s) Required Intervention;
Patient Age81 YR
Patient Weight85
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