MAUDE Adverse Event Report: SORIN GROUP ITALIA S.R.L. - CRM FACILITY INTENSIA; DEFIBRILLATOR, AUTOMATIC IMPLANTABLE CARDIOVERTER, WITH CRT-D

Model Number INTENSIA CRT-D 174

Device Problem Incorrect Interpretation of Signal (1543)

Patient Problems No Known Impact Or Consequence To Patient (2692); No Clinical Signs, Symptoms or Conditions (4582)

Event Date 02/01/2021

Event Type  malfunction  

Event Description

Reportedly, during a procedure to replace the subject crt-d, it was observed that an r-wave amplitude value displayed on the programmer screen was around 1mv, while during sensing tests, the amplitude of the detected r-waves is above 8mv.Based on preliminary analysis results, no anomaly is suspected on the subject crt-d.

Event Description

Reportedly, during a procedure to replace the subject crt-d, it was observed that an r-wave amplitude value displayed on the programmer screen was around 1mv, while during sensing tests, the amplitude of the detected r-waves is above 8mv.Based on preliminary analysis results, no anomaly is suspected on the subject crt-d.

Manufacturer Narrative

Please refer to the attached analysis report.

• Brand Name: INTENSIA
• Type of Device: DEFIBRILLATOR, AUTOMATIC IMPLANTABLE CARDIOVERTER, WITH CRT-D
• Manufacturer (Section D): SORIN GROUP ITALIA S.R.L. - CRM FACILITY; via crescentino s.n.; .; saluggia (vc), 13040 ; IT 13040
• Manufacturer (Section G): SORIN GROUP ITALIA SRL VIA CRESCENTINO 13040 SALUG; via crescentino s.n.; .; saluggia (vc), 13040 ; IT 13040
• Manufacturer Contact: elodie vincent ; via crescentino s.n.; .; saluggia (vc), 13040 ; IT 13040 ; 146013429
• MDR Report Key: 11364566
• MDR Text Key: 234456361
• Report Number: 1000165971-2021-00305
• 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: Company Representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 12/21/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/23/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 08/04/2015
• Device Model Number: INTENSIA CRT-D 174
• Device Catalogue Number: INTENSIA CRT-D 174
• Device Lot Number: 2834
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 02/01/2021
• Date Manufacturer Received: 11/23/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 07/04/2014
• 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