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

Model Number PARADYM RF CRT-D 9750

Device Problems Inappropriate/Inadequate Shock/Stimulation (1574); Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Shock (2072)

Event Date 02/05/2016

Event Type  Injury  

Event Description

Reportedly, the patient received inappropriate shock.The physician decided to take the right ventricular lead and cap the pace sense part of it and keep the two shocking coils active and said it was due to noise.He then placed a new lead as the right ventricular lead for pace sensing.After this the patient decided to go for a second opinion and it was decided to replace the device in case it was due to the device and not the leads.It was found also that the atrial lead was cut so they decided to cap and move the right ventricular lead to replace the atrial lead.Then they added a right ventricular lead as the new for pace/sensing.The subject icd will be returned for analysis.

Manufacturer Narrative

Preliminary analysis of the returned device confirmed it operated within specifications.

Event Description

Reportedly, the patient received inappropriate shock.The physician decided to take the right ventricular lead and cap the pace sense part of it and keep the two shocking coils active and said it was due to noise.He then placed a new lead as the right ventricular lead for pace sensing.After this the patient decided to go for a second opinion and it was decided to replace the device in case it was due to the device and not the leads.It was found also that the atrial lead was cut so they decided to cap and move the right ventricular lead to replace the atrial lead.Then they added a right ventricular lead as the new for pace/sensing.The subject icd will be returned for analysis.

Event Description

Reportedly, the patient received inappropriate shock.The physician decided to take the right ventricular lead and cap the pace sense part of it and keep the two shocking coils active and said it was due to noise.He then placed a new lead as the right ventricular lead for pace sensing.After this the patient decided to go for a second opinion and it was decided to replace the device in case it was due to the device and not the leads.It was found also that the atrial lead was cut so they decided to cap and move the right ventricular lead to replace the atrial lead.Then they added a right ventricular lead as the new for pace/sensing.The subject icd will be returned for analysis.

• Brand Name: PARADYM
• 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: 5480362
• MDR Text Key: 39676286
• Report Number: 1000165971-2016-00151
• Device Sequence Number: 1
• Product Code: NIK
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: PP060027
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date: 03/03/2016

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 Date: 01/12/2014
• Device Model Number: PARADYM RF CRT-D 9750
• Device Catalogue Number: PARADYM RF CRT-D 9750
• Device Lot Number: 2675
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/03/2016
• Is the Reporter a Health Professional?: Yes
• Distributor Facility Aware Date: 03/03/2016
• Event Location: Hospital
• Initial Date Manufacturer Received: 03/03/2016
• Initial Date FDA Received: 03/04/2016
• Supplement Dates Manufacturer Received: Not provided; Not provided
• Supplement Dates FDA Received: 06/27/2016; 07/04/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 12/12/2012
• 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; Required Intervention