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 Problem Difficult to Interrogate (1331)

Patient Problem Discomfort (2330)

Event Date 06/21/2016

Event Type  malfunction  

Event Description

Reportedly, the patient was admitted to emergency for discomfort and the patient was found in bradycardia (30bpm).The interrogation of the icd was not possible (no leds on the programmer¿s head).The device did not pace and no answer to magnet application.The same operation was attempted with another programmer without success.Review of previous follow-up early 2016 revealed no abnormality and battery voltage was normal (2.99v), the device was programmed in ddd mode (40min-1).Device was replaced on (b)(6) 2016 and will be returned for analysis.

Event Description

Reportedly, the patient was admitted to emergency for discomfort and the patient was found in bradycardia (30bpm).The interrogation of the icd was not possible (no leds on the programmer¿s head).The device did not pace and no answer to magnet application.The same operation was attempted with another programmer without success.Review of previous follow-up early 2016 revealed no abnormality and battery voltage was normal (2.99v), the device was programmed in ddd mode (40min-1).Device was replaced on (b)(6) 2016 and will be returned for analysis.

• 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: 5808539
• MDR Text Key: 50001622
• Report Number: 1000165971-2016-00425
• Device Sequence Number: 1
• Product Code: NIK
• Combination Product (y/n): N
• Reporter Country Code: FR
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 06/21/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/20/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 02/11/2014
• Device Model Number: PARADYM RF SONR CRT-D 9770
• Device Catalogue Number: PARADYM RF SONR CRT-D 9770
• Device Lot Number: 2677
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/05/2016
• Is the Reporter a Health Professional?: Yes
• Distributor Facility Aware Date: 06/21/2016
• Date Manufacturer Received: 10/21/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 01/11/2013
• Is the Device Single Use?: Yes
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention