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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 Use of Device Problem (1670)
Patient Problem Insufficient Information (4580)
Event Date 09/04/2022
Event Type  Injury  
Manufacturer Narrative
Medwatch report (mw5112306) was received.
 
Event Description
It was reported via a medwatch report that a serious injury may have occurred related to the patient's assurity pacemaker.It was also mentioned that the patient was concerned about abbott's available recall information found online.
 
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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
richard williamson
15900 valley view court
sylmar, CA 91342
MDR Report Key15727023
MDR Text Key303027447
Report Number2017865-2022-44150
Device Sequence Number1
Product Code LWP
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 User Facility
Reporter Occupation Non-Healthcare Professional
Type of Report Initial
Report Date 11/03/2022
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? No
Device Operator Health Professional
Device Model NumberPM2272
Device Catalogue NumberPM2272
Was Device Available for Evaluation? No
Was the Report Sent to FDA? Yes
Initial Date Manufacturer Received 10/14/2022
Initial Date FDA Received11/04/2022
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
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 Outcome(s) Other;
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