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 Therapeutic or Diagnostic Output Failure (3023)

Patient Problem Ventricular Tachycardia (2132)

Event Date 05/11/2017

Event Type  malfunction  

Event Description

Reportedly, during an emergency procedure with a patient having a vt, atp should be given manually.The device was interrogated and the physician wanted to deliver atp therapy.During the phase in which the programmer showed in the top line "aida reading," the physician tapped the eps screen and the atp button.Nothing happened.No atp was delivered.After several attempts the physician tried to simulate atp by doing a pacing threshold test with a very high frequency.The pacing was delivered but did not terminate the tachycardia.Finally the physician tried another sequence of atp via the eps screen.The message aida reading was gone.This sequence was successful.Preliminary analysis showed that reported issue was due to telemetry errors.In addition, it was observed that rrt point has been reached.Recommendations have been provided to explant the device.

Manufacturer Narrative

Please refer to the attached analysis report.

Event Description

Reportedly, during an emergency procedure with a patient having a vt, atp should be given manually.The device was interrogated and the physician wanted to deliver atp therapy.During the phase in which the programmer showed in the top line "aida reading», the physician tapped the eps screen and the atp button.Nothing happened.No atp was delivered.After several attempts the physician tried to simulate atp by doing a pacing threshold test with a very high frequency.The pacing was delivered but did not terminate the tachycardia.Finally the physician tried another sequence of atp via the eps screen.The message aida reading was gone.This sequence was successful.Preliminary analysis showed that reported issue was due to telemetry errors.In addition, it was observed that rrt point has been reached.Recommendations have been provided to explant the device.

• 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 VIA CRESCENTINO 13040 SALUGGIA; 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: 6617723
• MDR Text Key: 76969216
• Report Number: 1000165971-2017-00454
• Device Sequence Number: 1
• Product Code: NIK
• Combination Product (y/n): N
• Reporter Country Code: NL
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Reporter Occupation: Biomedical Engineer
• Type of Report: Initial,Followup
• Report Date: 05/11/2017

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: 05/02/2011
• Device Model Number: PARADYM RF SONR CRT-D 9770
• Device Catalogue Number: PARADYM RF SONR CRT-D 9770
• Device Lot Number: 2493
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 05/11/2017
• Event Location: Hospital
• Initial Date Manufacturer Received: 05/11/2017
• Initial Date FDA Received: 06/07/2017
• Supplement Dates Manufacturer Received: 10/20/2017
• Supplement Dates FDA Received: 11/17/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 11/02/2010
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Congenital Anomaly