MAUDE Adverse Event Report: SORIN GROUP ITALIA S.R.L. - CRM FACILITY REPLY; PULSE GENERATOR, PACEMAKER, IMPLANTABLE, WITH CARDIAC RESYNCHRONIZATION (CRT-P)

Model Number REPLY CRT-P

Device Problem Battery Problem: Low Impedance (2973)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 01/24/2017

Event Type  malfunction  

Manufacturer Narrative

Refer attached report.

Event Description

Reportedly, at first interrogation before implantation the device showed a battery impedance of 4.18 kohms.To ensure not to implant a device with low battery another device was used.It was reported also that the device was exposed to cold temperature before the interrogation in its commercial packaging.

• Brand Name: REPLY
• Type of Device: PULSE GENERATOR, PACEMAKER, IMPLANTABLE, WITH CARDIAC RESYNCHRONIZATION (CRT-P)
• 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: 6335923
• MDR Text Key: 67932268
• Report Number: 1000165971-2017-00120
• Device Sequence Number: 1
• Product Code: NKE
• UDI-Device Identifier: 08031527014173
• UDI-Public: (01)08031527014173(11)150902(17)170402
• Combination Product (y/n): N
• Reporter Country Code: SZ
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 01/24/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/16/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 04/02/2017
• Device Model Number: REPLY CRT-P
• Device Catalogue Number: REPLY CRT-P
• Device Lot Number: S0113
• Was Device Available for Evaluation?: No
• Distributor Facility Aware Date: 01/24/2017
• Event Location: Hospital
• Date Manufacturer Received: 01/24/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 09/02/2015
• 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