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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 Separation Failure (2547)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 05/11/2020
Event Type  malfunction  
Manufacturer Narrative
The results, method, and conclusion codes along with investigation results will be provided in the final report.
 
Event Description
During a device upgrade procedure, the leads were unable to be removed from the device header after loosening the set screws.The header was taken apart to separate the leads from the device.The patient was in stable condition following the procedure.
 
Manufacturer Narrative
Additional information: d10, h3, h6 the reported event of unable to remove the right atrial lead and right ventricular lead from the device header was not confirmed.The header was broken apart with only pieces of it returned.No foreign material or anomalies were noted in the pieces that would cause the inability to remove the leads from the header.No further analysis could be performed due to the damage to the header and an insufficient portion of the header was returned from the field to make an evaluation of the problem.Furthermore, the device battery voltage was above elective replacement indicator (eri) level.
 
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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
MDR Report Key10089263
MDR Text Key192058264
Report Number2017865-2020-06599
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,foreig
Type of Report Initial,Followup
Report Date 08/21/2020
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 Date07/31/2019
Device Model NumberPM2272
Device Catalogue NumberPM2272
Device Lot NumberP000055536
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer06/03/2020
Was the Report Sent to FDA? No
Initial Date Manufacturer Received 05/11/2020
Initial Date FDA Received05/26/2020
Supplement Dates Manufacturer Received08/17/2020
Supplement Dates FDA Received08/21/2020
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
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