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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: MICROPORT CRM S.R.L. TEO; IMPLANTABLE PULSE GENERATOR, PACEMAKER (NON-CRT)

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MICROPORT CRM S.R.L. TEO; IMPLANTABLE PULSE GENERATOR, PACEMAKER (NON-CRT) Back to Search Results
Model Number TEO DR
Device Problem Missing Test Results (3267)
Patient Problem No Information (3190)
Event Date 10/22/2019
Event Type  malfunction  
Manufacturer Narrative
The device involved in this mdr report is not approved in the unites states; however, it is similar to a device manufactured by sorin that was cleared or approved by fda for marketing in the united states.
 
Event Description
Reportedly, on (b)(6) 2019, during a follow-up after the implantation of the subject device, tests were performed but the impedance, threshold and detection tests values were missing in the printout; however, these data were properly displayed on the screen.On (b)(6) 2019, when checking the recorded interrogation files, it was suspected that the aforementioned data were not saved.The tests were performed manually and the event occurred with two orchestra programmers.
 
Event Description
Reportedly, during the follow-up after the implantation of the subject device on (b)(6) 2019, tests were performed manually but the impedance, threshold and detection tests values were missing in the printout; however, these data were properly displayed on the screen.On 18 november 2019, when checking the recorded interrogation files with two different programmers, it was suspected that the aforementioned data were not saved.
 
Event Description
Reportedly, during the follow-up after the implantation of the subject device on (b)(6)2019, tests were performed manually but the impedance, threshold and detection tests values were missing in the printout; however, these data were properly displayed on the screen.On (b)(6) 2019, when checking the recorded interrogation files with two different programmers, it was suspected that the aforementioned data were not saved.
 
Manufacturer Narrative
Preliminary analysis results showed that the device behaved as specified.B3 was modified: the correct event date is (b)(6) 2019.B5 was corrected accordingly.
 
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Brand Name
TEO
Type of Device
IMPLANTABLE PULSE GENERATOR, PACEMAKER (NON-CRT)
Manufacturer (Section D)
MICROPORT CRM S.R.L.
parc d'affaires noveos 4 avenue reaumur
clamart 92140
FR  92140
MDR Report Key9433759
MDR Text Key177379600
Report Number1000165971-2019-00678
Device Sequence Number1
Product Code LWP
UDI-Device Identifier08031527017204
UDI-Public(01)08031527017204(11)190711(17)210711
Combination Product (y/n)N
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type health professional
Type of Report Initial,Followup,Followup
Report Date 04/15/2020
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 Date07/11/2021
Device Model NumberTEO DR
Device Catalogue NumberTEO DR
Device Lot NumberS0389
Was Device Available for Evaluation? No
Was the Report Sent to FDA? No
Distributor Facility Aware Date11/15/2019
Event Location Hospital
Initial Date Manufacturer Received 11/15/2019
Initial Date FDA Received12/06/2019
Supplement Dates Manufacturer Received01/03/2020
03/27/2020
Supplement Dates FDA Received01/27/2020
04/15/2020
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
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