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U.S. Department of Health and Human Services

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

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MICROPORT CRM S.R.L. ENO; IMPLANTABLE PULSE GENERATOR, PACEMAKER (NON-CRT) Back to Search Results
Model Number ENO SR
Device Problem Pacing Inadequately (1442)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 09/22/2021
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 sorin that was cleared or approved by fda for marketing in the united states.
 
Event Description
Reportedly, the patient was programmed in aai mode.The patient visited the physician for an mri adjustment and the physician programmed the device in '24-hour manual mri, aoo, 80 min-1'.However, on the ecg before the exam, the pacing rate was 60 min-1.After the mri, the physician reprogramed the pacemaker in aai mode.
 
Manufacturer Narrative
Please refer to the attached analysis report.
 
Event Description
Reportedly, the patient was programmed in aai mode.The patient visited the physician for an mri adjustment and the physician programmed the device in '24-hour manual mri, aoo, 80 min-1'.However, on the ecg before the exam, the pacing rate was 60 min-1.After the mri, the physician reprogramed the pacemaker in aai mode.
 
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Brand Name
ENO
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 Key12679332
MDR Text Key277874448
Report Number1000165971-2021-00693
Device Sequence Number1
Product Code LWP
Combination Product (y/n)N
Reporter Country CodeFR
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Health Professional
Reporter Occupation Other
Type of Report Initial,Followup
Report Date 12/16/2021
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 Model NumberENO SR
Device Catalogue NumberENO SR
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? No
Initial Date Manufacturer Received 09/22/2021
Initial Date FDA Received10/22/2021
Supplement Dates Manufacturer Received12/14/2021
Supplement Dates FDA Received12/16/2021
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
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