MAUDE Adverse Event Report: SORIN GROUP ITALIA S.R.L. - CRM FACILITY PARADYM; DEFIBRILLATOR, IMPLANTABLE, DUAL-CHAMBER

Model Number PARADYM VR 8250

Device Problem Reset Problem (3019)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 07/15/2014

Event Type  Injury  

Event Description

During scheduled follow-up, the physician detected a reset warning message on the programmer screen.Preliminary analysis confirmed the reported issue and revealed that shock therapy was inhibited.Patient care recommendations have been provided.Recovery of normal icd behavior was confirmed afterwards.

Manufacturer Narrative

Further investigations allowed to confirm with certainty the root cause of the reported event (temporary abrupt decrease of the device internal power supply that occurred during a charge time test).

Event Description

During scheduled follow-up, the physician detected a reset warning message on the programmer screen.Preliminary analysis confirmed the reported issue and revealed that shock therapy was inhibited.Patient care recommendations have been provided.Recovery of normal icd behavior was confirmed afterwards.

Event Description

During scheduled follow-up, the physician detected a reset warning message on the programmer screen.Preliminary analysis confirmed the reported issue and revealed that shock therapy was inhibited.Patient care recommendations have been provided.Recovery of normal icd behavior was confirmed afterwards.

• Brand Name: PARADYM
• 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 9214 0; FR 92140
• Manufacturer (Section G): SORIN GROUP ITALIA SRL VIA CRESCENTINO 13040 SALUGGIA ITALY; parc d'affaires noveos 4 avenue réaumur; .; clamart 9214 0; FR 92140
• Manufacturer Contact: elodie vincent ; parc d'affaires noveos 4 avenue réaumur; .; clamart 92140 ; FR 92140 ; 0146013665
• MDR Report Key: 4001745
• MDR Text Key: 20860735
• Report Number: 1000165971-2014-00466
• Device Sequence Number: 1
• Product Code: MRM
• Combination Product (y/n): N
• Reporter Country Code: GM
• PMA/PMN Number: PP980049
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional
• Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date: 07/15/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/12/2014
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 07/17/2014
• Device Model Number: PARADYM VR 8250
• Device Catalogue Number: PARADYM VR 8250
• Device Lot Number: 2728
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Distributor Facility Aware Date: 07/15/2014
• Event Location: Hospital
• Date Manufacturer Received: 09/19/2014
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 06/17/2013
• 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): Required Intervention