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 CRT-D 8750

Device Problem Pacing Inadequately (1442)

Patient Problem Dyspnea (1816)

Event Date 11/24/2016

Event Type  Injury  

Event Description

Reportedly, during the scheduled follow-up on (b)(6) 2016, the patient complained from dyspnea during effort since about ten days.Upon interrogation of the subject icd, no acceleration of the cardiac rhythm was recorded in the device memories for the last few days, whereas the rate response was programmed.Reportedly, this behavior has never been observed before.Several tests were performed during the follow-up (parameters reprogramming, tests in real time to try to activate the accelerometer), without any change observed.Preliminary analysis confirmed the reported behavior.Recommendations were provided on (b)(6) 2016 (procedure to attempt to reactivate the accelerometer).Reportedly, recommendations were applied during the follow-up performed on (b)(6) 2016, and rate response associated to the accelerometer sensor was observed again.Next follow-up was reportedly scheduled in (b)(6) 2017.

Manufacturer Narrative

During the last interrogation performed on (b)(6) 2017, it was observed that the cardiac rate was constantly at the basic rate since last follow-up on (b)(6) 2016.The accelerometer sensor was back to being unresponsive, therefore the subject icd was replaced on (b)(6) 2017.The icd will be returned for analysis.

Event Description

Reportedly, during the scheduled follow-up on (b)(6) 2016, the patient complained from dyspnea during effort since about ten days.Upon interrogation of the subject icd, no acceleration of the cardiac rhythm was recorded in the device memories for the last few days, whereas the rate response was programmed.Reportedly, this behavior has never been observed before.Several tests were performed during the follow-up (parameters reprogramming, tests in real time to try to activate the accelerometer), without any change observed.Preliminary analysis confirmed the reported behavior.Recommendations were provided on (b)(6) 2016 (procedure to attempt to reactivate the accelerometer).Reportedly, recommendations were applied during the follow-up performed on (b)(6) 2016, and rate response associated to the accelerometer sensor was observed again.Next follow-up was reportedly scheduled in (b)(6) 2017.

Manufacturer Narrative

Preliminary analysis of the returned device revealed a possible issue on the sensor.

Event Description

Reportedly, during the scheduled follow-up on (b)(6) 2016, the patient complained from dyspnea during effort since about ten days.Upon interrogation of the subject icd, no acceleration of the cardiac rhythm was recorded in the device memories for the last few days, whereas the rate response was programmed.Reportedly, this behavior has never been observed before.Several tests were performed during the follow-up (parameters reprogramming, tests in real time to try to activate the accelerometer), without any change observed.Preliminary analysis confirmed the reported behavior.Recommendations were provided on (b)(6) 2016 (procedure to attempt to reactivate the accelerometer).Reportedly, recommendations were applied during the follow-up performed on (b)(6) 2016, and rate response associated to the accelerometer sensor was observed again.Next follow-up was reportedly scheduled in (b)(6) 2017.

Manufacturer Narrative

Please refer to the attached investigation report.

Event Description

Reportedly, during the scheduled follow-up on 6 december 2016, the patient complained from dyspnea during effort since about ten days.Upon interrogation of the subject icd, no acceleration of the cardiac rhythm was recorded in the device memories for the last few days, whereas the rate response was programmed.Reportedly, this behavior has never been observed before.Several tests were performed during the follow-up (parameters reprogramming, tests in real time to try to activate the accelerometer), without any change observed.Preliminary analysis confirmed the reported behavior.Recommendations were provided on (b)(6) 2016 (procedure to attempt to reactivate the accelerometer).Reportedly, recommendations were applied during the follow-up performed on 15 december 2016, and rate response associated to the accelerometer sensor was observed again.Next follow-up was reportedly scheduled in january 2017.

• 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: 6202107
• MDR Text Key: 63200048
• Report Number: 1000165971-2016-00852
• Device Sequence Number: 1
• Product Code: NIK
• Combination Product (y/n): N
• Reporter Country Code: FR
• PMA/PMN Number: P060027
• 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,Followup
• Report Date: 12/06/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/23/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 08/29/2011
• Device Model Number: PARADYM CRT-D 8750
• Device Catalogue Number: PARADYM CRT-D 8750
• Device Lot Number: 2472
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/27/2017
• Is the Reporter a Health Professional?: Yes
• Distributor Facility Aware Date: 12/06/2016
• Event Location: Hospital
• Date Manufacturer Received: 12/07/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 07/29/2010
• 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