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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: SORIN GROUP ITALIA S.R.L. - CRM FACILITY PLATINIUM; DEFIBRILLATOR, IMPLANTABLE, DUAL-CHAMBER
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SORIN GROUP ITALIA S.R.L. - CRM FACILITY PLATINIUM; DEFIBRILLATOR, IMPLANTABLE, DUAL-CHAMBER Back to Search Results
Model Number PLATINIUM DR 1540
Device Problems High impedance (1291); Failure to Sense (1559); No Pacing (3268)
Patient Problem Headache (1880)
Event Date 06/03/2019
Event Type  Injury  
Event Description
The defibrillation system was implanted on (b)(6) 2018.Reportedly, a few days after implantation, a rv coil continuity value saturated at 3000 ohms was measured.Since then, the patient had been under remote monitoring.On (b)(6) 2019, the patient was hospitalized for headaches (not device-related).During the follow-up, leads impedances were measured above 3000 ohms on both channels and flat egms were observed.The icd does not pace and sense anymore.Sensing tests with higher sensitivity values and high pacing outputs were performed.The user also reprogrammed the icd in ooo mode and back in ddd mode but the situation remained unchanged.It was reported that no medical procedure or examination occurred that could explain the phenomenon.The icd was explanted on (b)(6) 2019 and was returned for analysis.
 
Event Description
The defibrillation system was implanted on (b)(6)2018.Reportedly, a few days after implantation, a rv coil continuity value saturated at 3000 ohms was measured.Since then, the patient had been under remote monitoring.On (b)(6)2019 , the patient was hospitalized for headaches (not device-related).During the follow-up, leads impedances were measured above 3000 ohms on both channels and flat egms were observed.The icd does not pace and sense anymore.Sensing tests with higher sensitivity values and high pacing outputs were performed.The user also reprogrammed the icd in ooo mode and back in ddd mode but the situation remained unchanged.It was reported that no medical procedure or examination occurred that could explain the phenomenon.The icd was explanted on (b)(6)2019 and was returned for analysis.
 
Manufacturer Narrative
Please refer to the attached analysis report.
 
Manufacturer Narrative
Preliminary analysis of the returned device confirmed a hardware failure at the level of an integrated circuit.
 
Event Description
The defibrillation system was implanted on (b)(6) 2018.Reportedly, a few days after implantation, a rv coil continuity value saturated at 3000 ohms was measured.Since then, the patient had been under remote monitoring.On (b)(6) 2019, the patient was hospitalized for headaches (not device-related).During the follow-up, leads impedances were measured above 3000 ohms on both channels and flat egms were observed.The icd does not pace and sense anymore.Sensing tests with higher sensitivity values and high pacing outputs were performed.The user also reprogrammed the icd in ooo mode and back in ddd mode but the situation remained unchanged.It was reported that no medical procedure or examination occurred that could explain the phenomenon.The icd was explanted on (b)(6) 2019 and was returned for analysis.
 
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Brand Name
PLATINIUM
Type of Device
DEFIBRILLATOR, IMPLANTABLE, DUAL-CHAMBER
Manufacturer (Section D)
SORIN GROUP ITALIA S.R.L. - CRM FACILITY
parc d'affaires noveos 4 avenue réaumur
.
clamart 92140
FR  92140
MDR Report Key8743199
MDR Text Key149485642
Report Number1000165971-2019-00379
Device Sequence Number1
Product Code MRM
UDI-Device Identifier08031527014401
UDI-Public(01)08031527014401(11)180517(17)191217
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,Followup
Report Date 10/21/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received06/28/2019
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator Health Professional
Device Expiration Date12/17/2019
Device Model NumberPLATINIUM DR 1540
Device Catalogue NumberPLATINIUM DR 1540
Device Lot NumberS0317
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer06/12/2019
Was the Report Sent to FDA? No
Distributor Facility Aware Date06/03/2019
Event Location Hospital
Date Manufacturer Received09/26/2019
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Patient Outcome(s) Required Intervention;
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