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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 VR 1240
Device Problem Device Displays Incorrect Message (2591)
Patient Problems No Known Impact Or Consequence To Patient (2692); No Clinical Signs, Symptoms or Conditions (4582)
Event Date 12/18/2020
Event Type  malfunction  
Event Description
Reportedly, shortly after implantation of the subject icd, a message was displayed to the user, stating that ventricular oversensing was suspected.In addition, at first interrogation of the device, a message about a necessary initialization appeared and was accepted by the user.
 
Event Description
Reportedly, shortly after implantation of the subject icd, a message was displayed to the user, stating that ventricular oversensing was suspected.In addition, at first interrogation of the device, a message about a necessary initialization appeared and was accepted by the user.
 
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 Key11180294
MDR Text Key234804524
Report Number1000165971-2021-00232
Device Sequence Number1
Product Code MRM
UDI-Device Identifier08031527014395
UDI-Public(01)08031527014395(11)190709(17)210209
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 03/19/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received01/15/2021
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Expiration Date02/09/2021
Device Model NumberPLATINIUM VR 1240
Device Catalogue NumberPLATINIUM VR 1240
Device Lot NumberS0389
Was Device Available for Evaluation? No
Was the Report Sent to FDA? No
Distributor Facility Aware Date12/21/2020
Event Location Hospital
Date Manufacturer Received02/22/2021
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
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