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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: MICROPORT CRM S.R.L. PLATINIUM; DEFIBRILLATOR, AUTOMATIC IMPLANTABLE CARDIOVERTER,WITH CRT-D

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MICROPORT CRM S.R.L. PLATINIUM; DEFIBRILLATOR, AUTOMATIC IMPLANTABLE CARDIOVERTER,WITH CRT-D Back to Search Results
Model Number PLATINIUM CRT-D 1711
Device Problem Pacing Intermittently (1443)
Patient Problems Asystole (4442); No Clinical Signs, Symptoms or Conditions (4582)
Event Date 03/25/2021
Event Type  Injury  
Event Description
During an intervention of left ventricular lead revision, the subject crt-d was programmed to doo prior to the procedure.The reporter used a medtronic plasmablade to prepare the pocket.Using the coag mode of the plasmablade, the platinium device reportedly inhibited stimulation despite being in doo mode.However, the device stimulated in cut mode as expected.
 
Manufacturer Narrative
Updated.
 
Event Description
During an intervention of left ventricular lead revision, the subject crt-d was programmed to doo prior to the procedure.The reporter used a medtronic plasmablade to prepare the pocket.Using the coag mode of the plasmablade, the platinium device reportedly inhibited stimulation despite being in doo mode.However, the device stimulated in cut mode as expected.
 
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Brand Name
PLATINIUM
Type of Device
DEFIBRILLATOR, AUTOMATIC IMPLANTABLE CARDIOVERTER,WITH CRT-D
Manufacturer (Section D)
MICROPORT CRM S.R.L.
via crescentino s.n.
saluggia (vc), 13040
IT  13040
MDR Report Key11716042
MDR Text Key247018546
Report Number1000165971-2021-00409
Device Sequence Number1
Product Code NIK
UDI-Device Identifier08031527014371
UDI-Public(01)08031527014371(11)160503(17)171203
Combination Product (y/n)N
PMA/PMN Number
P060027
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type health professional
Type of Report Initial,Followup
Report Date 07/28/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator Health Professional
Device Expiration Date12/03/2017
Device Model NumberPLATINIUM CRT-D 1711
Device Catalogue NumberPLATINIUM CRT-D 1711
Device Lot NumberS0176
Was Device Available for Evaluation? No
Initial Date Manufacturer Received 03/30/2021
Initial Date FDA Received04/23/2021
Supplement Dates Manufacturer Received06/29/2021
Supplement Dates FDA Received07/28/2021
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Patient Outcome(s) Required Intervention;
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