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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: MICROPORT CRM S.R.L. BOREA DR 1500; IMPLANTABLE PULSE GENERATOR, PACEMAKER (NON-CRT)
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MICROPORT CRM S.R.L. BOREA DR 1500; IMPLANTABLE PULSE GENERATOR, PACEMAKER (NON-CRT) Back to Search Results
Model Number BOREA DR 1500
Device Problem Problem with Software Installation (3013)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 11/03/2022
Event Type  malfunction  
Manufacturer Narrative
The device involved in this mdr report is not approved in the united states; however, it is similar to a device manufactured by microport crm that was cleared or approved by fda for marketing in the united states.
 
Event Description
Whilst carrying out the bluetooth wireless upgrade 3.12 the device required reinitialising which i did 3 times as i couldn't move passed this stage and resulted in me removing the device as i couldn't leave it in standby.This happened to 2 devices complaint for the other one to follow.I did have a small pile of 4 devices to the side around 1/2 meter away whilst carrying out the upgrades.
 
Event Description
Whilst carrying out the bluetooth wireless upgrade 3.12 the device required reinitialising which i did 3 times as i couldn't move passed this stage and resulted in me removing the device as i couldn't leave it in standby.This happened to 2 devices complaint for the other one to follow.I did have a small pile of 4 devices to the side around 1/2 meter away whilst carrying out the upgrades.
 
Manufacturer Narrative
Please refer to the attached analysis report.
 
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Brand Name
BOREA DR 1500
Type of Device
IMPLANTABLE PULSE GENERATOR, PACEMAKER (NON-CRT)
Manufacturer (Section D)
MICROPORT CRM S.R.L.
via crescentino s.n
saluggia (vc) 13040
IT  13040
Manufacturer (Section G)
MICROPORT CRM S.R.L.
via crescentino s.n
saluggia (vc) 13040
IT   13040
Manufacturer Contact
elodie vincent
via crescentino s.n
saluggia (vc) 13040
IT   13040
MDR Report Key15751084
MDR Text Key303901904
Report Number1000165971-2022-00494
Device Sequence Number1
Product Code LWP
Combination Product (y/n)N
Reporter Country CodeUK
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,Followup
Report Date 12/12/2022
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 Model NumberBOREA DR 1500
Device Catalogue NumberBOREA DR 1500
Was Device Available for Evaluation? No
Was the Report Sent to FDA? No
Initial Date Manufacturer Received 11/03/2022
Initial Date FDA Received11/08/2022
Supplement Dates Manufacturer Received12/12/2022
Supplement Dates FDA Received12/12/2022
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 EthnicityNon Hispanic
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