MAUDE Adverse Event Report: SORIN GROUP ITALIA S.R.L. - CRM FACILITY REPLY; PULSE GENERATOR, PERMANENT, IMPLANTABLE

Model Number REPLY SR

Device Problems Failure to Transmit Record (1521); Data Problem (3196)

Patient Problems Ventricular Tachycardia (2132); Electric Shock (2554)

Event Date 12/01/2015

Event Type  Injury  

Event Description

On (b)(6) 2015, patient was transported to the hospital due to an attack of vt and received cardiopulmonary resuscitation with a dc defibrillator.On the 24 hours heart rate curve, spontaneous rhythm around 150min-1 was recorded when the patient was transported to the hospital.However, no egm was recorded in the device memories during the time the rate was around 150min-1.

Event Description

On (b)(6) 2015, patient was transported to the hospital due to an attack of vt and received cardiopulmonary resuscitation with a dc defibrillator.On the 24 hours heart rate curve, spontaneous rhythm around 150min-1 was recorded when the patient was transported to the hospital.However, no egm was recorded in the device memories during the time the rate was around 150min-1.

• Brand Name: REPLY
• Type of Device: PULSE GENERATOR, PERMANENT, IMPLANTABLE
• 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: 5317764
• MDR Text Key: 34112837
• Report Number: 1000165971-2015-00787
• Device Sequence Number: 1
• Product Code: NVZ
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: PP950029
• 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
• Report Date: 12/04/2015

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: Physician
• Device Expiration Date: 02/06/2011
• Device Model Number: REPLY SR
• Device Catalogue Number: REPLY SR
• Device Lot Number: 2416
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Distributor Facility Aware Date: 12/04/2015
• Event Location: Hospital
• Initial Date Manufacturer Received: 12/04/2015
• Initial Date FDA Received: 12/22/2015
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 01/22/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 07/06/2009
• 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