MAUDE Adverse Event Report: SORIN GROUP ITALIA S.R.L. - CRM FACILITY PARADYM RF; DEFIBRILLATOR, AUTO. IMPLANTABLE CARDIOVERTER, WITH CARDIAC RESYNCHRO. (CRT-D)

Model Number PARADYM RF SONR CRT-D 9770

Device Problems Over-Sensing (1438); Inappropriate/Inadequate Shock/Stimulation (1574)

Patient Problem Shock (2072)

Event Date 11/11/2016

Event Type  malfunction  

Event Description

Patient admitted in the hospital with the device delivering continuous shock therapies.Twenty five shocks were delivered.Reportedly, 15 egms recorded in device memory suggest that inappropriate therapies were delivered due to ventricular over-sensing.The rv coil continuity appears to be within normal range but has dropped by 70 degrees since the last follow-up.The r wave autosensing histograms show very small signal amplitudes across all zones.Therapies have been deactivated and the patient remained in the hospital.Preliminary analysis confirmed the reported event.The episodes recorded in device memory showed ventricular noise oversensing, due to a probable lead (volta sn (b)(4)) issue or lead /icd connection issue.Patient care recommendations have been provided to replace the rv lead and check the battery voltage of the subject icd.It was reported that a re-intervention was performed (the date is unknown) and the associated rv lead was extracted.

Manufacturer Narrative

The subject icd was explanted and will be returned for analysis.

Event Description

Patient admitted in the hospital with the device delivering continuous shock therapies; 25 shocks were delivered.Reportedly, 15 egms recorded in device memory suggest that inappropriate therapies were delivered due to ventricular over-sensing.The rv coil continuity appears to be within normal range but has dropped by 70 since the last follow-up.The r wave autosensing histograms show very small signal amplitudes across all zones.Therapies have been deactivated and the patient remained in the hospital.Preliminary analysis confirmed the reported event.The episodes recorded in device memory showed ventricular noise oversensing, due to a probable lead (volta sn (b)(4)) issue or lead /icd connection issue.Patient care recommendations have been provided to replace the rv lead and check the battery voltage of the subject icd.It was reported that a re-intervention was performed (the date is unknown) and the associated rv lead was extracted.

Manufacturer Narrative

Preliminiary analysis of the returned device did not reaveal any anomaly.

Event Description

Patient admitted in the hospital with the device delivering continuous shock therapies.25 shocks were delivered.Reportedly, 15 egms recorded in device memory suggest that inappropriate therapies were delivered due to ventricular over-sensing.The rv coil continuity appears to be within normal range but has dropped by 70 since the last follow-up.The r wave autosensing histograms show very small signal amplitudes across all zones.Therapies have been deactivated and the patient remained in the hospital.Preliminary analysis confirmed the reported event.The episodes recorded in device memory showed ventricular noise oversensing, due to a probable lead (volta sn (b)(4)) issue or lead /icd connection issue.Patient care recommendations have been provided to replace the rv lead and check the battery voltage of the subject icd.It was reported that a re-intervention was performed (the date is unknown) and the associated rv lead was extracted.

Event Description

Patient admitted in the hospital with the device delivering continuous shock therapies.25 shocks were delivered.Reportedly, 15 egms recorded in device memory suggest that inappropriate therapies were delivered due to ventricular over-sensing.The rv coil continuity appears to be within normal range but has dropped by 70 since the last follow-up.The r wave autosensing histograms show very small signal amplitudes across all zones.Therapies have been deactivated and the patient remained in the hospital.Preliminary analysis confirmed the reported event.The episodes recorded in device memory showed ventricular noise oversensing, due to a probable lead (volta sn (b)(4)) issue or lead /icd connection issue.Patient care recommendations have been provided to replace the rv lead and check the battery voltage of the subject icd.It was reported that a re-intervention was performed (the date is unknown) and the associated rv lead was extracted.

• Brand Name: PARADYM RF
• Type of Device: DEFIBRILLATOR, AUTO. IMPLANTABLE CARDIOVERTER, WITH CARDIAC RESYNCHRO. (CRT-D)
• Manufacturer (Section D): SORIN GROUP ITALIA S.R.L. - CRM FACILITY; parc d'affaires noveos 4 avenue réaumur; .; clamart 92140 ; FR 92140
• Manufacturer (Section G): SORIN GROUP ITALIA SRL VIA CRESCENTINO 13040 SALUGGIA ITALY; parc d'affaires noveos 4 avenue réaumur; .; clamart 92140 ; FR 92140
• Manufacturer Contact: elodie vincent ; parc d'affaires noveos 4 avenue réaumur; .; clamart 92140 ; FR 92140 ; 0146013665
• MDR Report Key: 6154681
• MDR Text Key: 62325022
• Report Number: 1000165971-2016-00798
• Device Sequence Number: 1
• Product Code: NIK
• Combination Product (y/n): N
• Reporter Country Code: UK
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Reporter Occupation: Health Professional
• Type of Report: Initial,Followup,Followup,Followup
• Report Date: 11/11/2016

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 Date: 11/30/2014
• Device Model Number: PARADYM RF SONR CRT-D 9770
• Device Catalogue Number: PARADYM RF SONR CRT-D 9770
• Device Lot Number: 2777
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/13/2017
• Is the Reporter a Health Professional?: Yes
• Distributor Facility Aware Date: 11/11/2016
• Event Location: Home
• Initial Date Manufacturer Received: 11/11/2016
• Initial Date FDA Received: 12/08/2016
• Supplement Dates Manufacturer Received: Not provided; Not provided; 07/25/2017
• Supplement Dates FDA Received: 01/24/2017; 03/16/2017; 07/26/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 10/30/2013
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization