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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: SORIN GROUP ITALIA S.R.L. - CRM FACILITY PARADYM RF; DEFIBRILLATOR, IMPLANTABLE, DUAL-CHAMBER
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SORIN GROUP ITALIA S.R.L. - CRM FACILITY PARADYM RF; DEFIBRILLATOR, IMPLANTABLE, DUAL-CHAMBER Back to Search Results
Model Number PARADYM RF VR 9250
Device Problems Failure to Interrogate (1332); Pacing Problem (1439)
Patient Problems No Known Impact Or Consequence To Patient (2692); No Clinical Signs, Symptoms or Conditions (4582)
Event Date 10/26/2020
Event Type  Injury  
Event Description
Reportedly, a follow-up was performed on (b)(6) 2020 and proper functioning of the subject icd was observed.The battery voltage was at 2.92v and the magnet rate was 87 bpm.The icd was programmed in vvi mode, 30min-1 with 100% of sensing.No episodes were recorded in the device memories, and no anomaly was observed on the ventricular lead impedance curve.On an ecg performed on (b)(6) 2020, a spontaneous sinus rhythm at 60 bpm was observed.On the same day, three interrogation attempts were performed with three different programmers.The icd could not be interrogated and no green leds were lit.No change of rhythm was observed when a magnet was placed over the device.Preliminary analysis results showed that normal battery depletion occurred as of (b)(6) 2020 (the recommended replacement time had not been reached at that date).The reported issue was confirmed by the analysis.As proper functioning of the device could not be guaranteed, recommendations were provided on (b)(6) 2020 to replace the device.The device was explanted on (b)(6) 2020 and returned for analysis.
 
Event Description
Reportedly, a follow-up was performed on (b)(6) 2020 and proper functioning of the subject icd was observed.The battery voltage was at 2.92v and the magnet rate was 87 bpm.The icd was programmed in vvi mode, 30min-1 with 100% of sensing.No episodes were recorded in the device memories, and no anomaly was observed on the ventricular lead impedance curve.On an ecg performed on (b)(6) 2020, a spontaneous sinus rhythm at 60 bpm was observed.On the same day, three interrogation attempts were performed with three different programmers.The icd could not be interrogated and no green leds were lit.No change of rhythm was observed when a magnet was placed over the device.Preliminary analysis results showed that normal battery depletion occurred as of (b)(6) 2020 (the recommended replacement time had not been reached at that date).The reported issue was confirmed by the analysis.As proper functioning of the device could not be guaranteed, recommendations were provided on (b)(6) 2020 to replace the device.The device was explanted on (b)(6) 2020 and returned for analysis.
 
Manufacturer Narrative
Expertise of the returned device revealed that upon reception, the device could not be interrogated and no pacing outputs were delivered.The root cause of the observed issue could not be determined based on available data.A battery failure cannot be excluded at this stage.
 
Event Description
Reportedly, a follow-up was performed on (b)(6) 2020 and proper functioning of the subject icd was observed.The battery voltage was at 2.92v and the magnet rate was 87 bpm.The icd was programmed in vvi mode, 30min-1 with 100% of sensing.No episodes were recorded in the device memories, and no anomaly was observed on the ventricular lead impedance curve.On an ecg performed on (b)(6) 2020, a spontaneous sinus rhythm at 60 bpm was observed.On the same day, three interrogation attempts were performed with three different programmers.The icd could not be interrogated and no green leds were lit.No change of rhythm was observed when a magnet was placed over the device.Preliminary analysis results showed that normal battery depletion occurred as of (b)(6) 2020 (the recommended replacement time had not been reached at that date).The reported issue was confirmed by the analysis.As proper functioning of the device could not be guaranteed, recommendations were provided on 27 october 2020 to replace the device.The device was explanted on 04 november 2020 and returned for analysis.
 
Manufacturer Narrative
Please refer to the attached analysis report.
 
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Brand Name
PARADYM RF
Type of Device
DEFIBRILLATOR, IMPLANTABLE, DUAL-CHAMBER
Manufacturer (Section D)
SORIN GROUP ITALIA S.R.L. - CRM FACILITY
via crescentino s.n
.
saluggia (vc), 13040
IT  13040
MDR Report Key10866756
MDR Text Key217064937
Report Number1000165971-2020-00746
Device Sequence Number1
Product Code MRM
Combination Product (y/n)N
PMA/PMN Number
P060027
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,health
Type of Report Initial,Followup,Followup
Report Date 04/23/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received11/19/2020
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator Health Professional
Device Expiration Date03/11/2014
Device Model NumberPARADYM RF VR 9250
Device Catalogue NumberPARADYM RF VR 9250
Device Lot Number2685
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer11/12/2020
Was the Report Sent to FDA? No
Distributor Facility Aware Date10/26/2020
Date Manufacturer Received03/30/2021
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Patient Outcome(s) Required Intervention;
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