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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: MICROPORT CRM S.R.L. PLATINIUM; DEFIBRILLATOR, IMPLANTABLE, DUAL-CHAMBER
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MICROPORT CRM S.R.L. PLATINIUM; DEFIBRILLATOR, IMPLANTABLE, DUAL-CHAMBER Back to Search Results
Model Number PLATINIUM DR 1540
Device Problems Display or Visual Feedback Problem (1184); Low impedance (2285)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 03/18/2021
Event Type  malfunction  
Event Description
Reportedly, the patient real time egms were not available in several remote monitoring reports.In addition, the atrial lead impedance is low.Preliminary analysis revealed that the absence of real time egm in the remote monitoring report resulted from an inadequate software management.The low atrial lead impedance measurements most probably resulted from an atrial lead issue.
 
Event Description
Reportedly, the patient real time egms were not available in several remote monitoring reports.In addition, the atrial lead impedance is low.Preliminary analysis revealed that the absence of real time egm in the remote monitoring report resulted from an inadequate software management.The low atrial lead impedance measurements most probably resulted from an atrial lead issue.
 
Manufacturer Narrative
Please refer to the attached analysis report.
 
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Brand Name
PLATINIUM
Type of Device
DEFIBRILLATOR, IMPLANTABLE, DUAL-CHAMBER
Manufacturer (Section D)
MICROPORT CRM S.R.L.
via crescentino s.n.
saluggia (vc), 13040
IT  13040
MDR Report Key11611063
MDR Text Key243830685
Report Number1000165971-2021-00376
Device Sequence Number1
Product Code MRM
UDI-Device Identifier08031527014401
UDI-Public(01)08031527014401(11)180420(17)191120
Combination Product (y/n)N
PMA/PMN Number
P980049
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type health professional
Type of Report Initial,Followup
Report Date 06/01/2021
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 Date11/20/2019
Device Model NumberPLATINIUM DR 1540
Device Catalogue NumberPLATINIUM DR 1540
Device Lot NumberS0313
Was Device Available for Evaluation? No
Initial Date Manufacturer Received 03/18/2021
Initial Date FDA Received04/02/2021
Supplement Dates Manufacturer Received05/06/2021
Supplement Dates FDA Received06/01/2021
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
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