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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ABBOTT ASSURITY MRI; IMPLANTABLE PACEMAKER PULSE GENERATOR

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ABBOTT 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 Date 07/19/2021
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: 2017865-2021-27338 and 2017865-2021-27340.Patient presented to the emergency room with episodes of presyncope and bradycardia.The device was interrogated and revealed an increase in capture threshold that resulted in intermittent loss of capture.The device was reprogrammed to resolve the capture anomalies.Diagnostic imaging was performed and revealed that the right atrial (ra) and right ventricular (rv) leads were stretched resulting in a lead slack anomaly.It was suspected that the ra and rv leads became stretched due to the pocket of the device being too large and causing the device to migrate in the pocket.A revision procedure was scheduled for the ra and rv leads.The ra lead was successfully repositioned.During the revision procedure, the rv lead became dislodged.The rv lead was explanted and replaced to resolve the event and the patient was stable.
 
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Brand Name
ASSURITY MRI
Type of Device
IMPLANTABLE PACEMAKER PULSE GENERATOR
Manufacturer (Section D)
ABBOTT
15900 valley view court
sylmar CA 91342
Manufacturer (Section G)
ABBOTT
15900 valley view court
sylmar CA 91342
Manufacturer Contact
sonali arangil
15900 valley view court
sylmar, CA 91342
MDR Report Key12282543
MDR Text Key265223132
Report Number2017865-2021-27557
Device Sequence Number1
Product Code LWP
UDI-Device Identifier05414734509589
UDI-Public05414734509589
Combination Product (y/n)N
Reporter Country CodeBE
PMA/PMN Number
P140033
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,foreig
Reporter Occupation Physician
Type of Report Initial
Report Date 08/05/2021
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 Date08/31/2022
Device Model NumberPM2272
Device Catalogue NumberPM2272
Device Lot NumberP000118001
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 Received08/05/2021
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured02/24/2021
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; TENDRIL STS
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