MAUDE Adverse Event Report: SORIN GROUP ITALIA S.R.L. ESPRIT

Model Number ESPRIT DR

Device Problems Over-Sensing (1438); Failure to Transmit Record (1521)

Patient Problem Ventricular Tachycardia (2132)

Event Date 12/02/2013

Event Type  Injury  

Event Description

Patient was admitted in hospital in emergency on (b)(6) 2013, because of ventricular tachycardia.Two external shocks were delivered to treat the vt.The pacemaker was interrogated after the shocks delivery and a first sensing test was performed.During this test, a strong noise was reportedly observed.Nevertheless, neither the noise episode nor the vt episode was stored in pacemaker memory.Then, further tests were performed, which reportedly showed normal behavior.Recommendations have been provided.

Manufacturer Narrative

This event concerns a device that was manufactured and used outside the united states.Analysis is pending.

• Brand Name: ESPRIT
• Manufacturer (Section D): SORIN GROUP ITALIA S.R.L.; saluggia ; IT
• Manufacturer (Section G): SORIN GROUP ITALIA S.R.L.; via crescentino s.n.; saluggia (vc) 1304 0; IT 13040
• Manufacturer Contact: e. vincent ; 4 avenue reaumur; parc d'affaires noveos; clamart cedex 92140 ; FR 92140 ; 46013687
• MDR Report Key: 3580856
• MDR Text Key: 4037161
• Report Number: 1000165971-2014-00010
• Device Sequence Number: 1
• Product Code: NVZ
• Combination Product (y/n): N
• Reporter Country Code: SP
• PMA/PMN Number: P950029
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 01/10/2014,12/19/2013

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 01/03/2015
• Device Model Number: ESPRIT DR
• Device Catalogue Number: ESPRIT DR
• Device Lot Number: 2720
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Event Location: Hospital
• Initial Date Manufacturer Received: 12/19/2013
• Initial Date FDA Received: 01/09/2014
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 06/01/2013
• 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