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

Model Number REPLY DR

Device Problem Invalid Sensing (2293)

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

Event Date 12/04/2014

Event Type  Injury  

Event Description

Reportedly, the patient brought into clinic due to a holter report showing inappropriate inhibition of ventricular pacing.According to the patient, he was not close to any emi source.During clinical follow-up on (b)(6) 2014, noise was recorded as "a" and "v" bursts in both leads.Provocative maneuvers were done and the noise was reproduced with vigorous arm movements (up and down).The incision site was not manipulated.It was reported that the sensitivity setting of both chambers have since been modified and 24 hour holter on (b)(6) 2014 showed appropriate safer operation since this reprogramming.Preliminary analysis confirmed the presence of non-physiological signals on both atrial and ventricular channels in some of the episodes stored in device memories (since (b)(6) 2014).Recommendations have been provided to the physician on (b)(6) 2014 , so as to check the functioning/integrity of the pacing system (pacemaker, leads and leads¿ connection).

Event Description

Reportedly, the patient brought into clinic due to a holter report showing inappropriate inhibition of ventricular pacing.According to the patient, he was not close to any emi source.During clinical follow-up on (b)(6) 2014, noise was recorded as a and v bursts in both leads.Provocative maneuvers were done and the noise was reproduced with vigorous arm movements (up and down).The incision site was not manipulated.It was reported that the sensitivity setting of both chambers have since been modified and 24 hour holter on (b)(6) 2014 showed appropriate safer operation since this reprogramming.Preliminary analysis confirmed the presence of non-physiological signals on both atrial and ventricular channels in some of the episodes stored in device memories (since (b)(6) 2014).Recommendations have been provided to the physician on (b)(6) 2014 , so as to check the functioning/integrity of the pacing system (pacemaker, leads and leads¿ connection).

Event Description

Reportedly, the patient brought into clinic due to a holter report showing inappropriate inhibition of ventricular pacing.According to the patient, he was not close to any emi source.During clinical follow-up on (b)(6) 2014, noise was recorded as a and v bursts in both leads.Provocative maneuvers were done and the noise was reproduced with vigorous arm movements (up and down).The incision site was not manipulated.It was reported that the sensitivity setting of both chambers have since been modified and 24 hour holter on (b)(6) 2014 showed appropriate safer operation since this reprogramming.Preliminary analysis confirmed the presence of non-physiological signals on both atrial and ventricular channels in some of the episodes stored in device memories (since october 2014).Recommendations have been provided to the physician on (b)(6) 2014 , so as to check the functioning/integrity of the pacing system (pacemaker, leads and leads¿ connection).

Manufacturer Narrative

It was reported that a follow-up was performed on (b)(6) 2014 and the x-ray result showed mild kinking of proximal lead within upper chest.No further noise episodes were noted during this follow-up.No changes were made at this visit and the next follow-up will be performed in 3 months.

• 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 9214 0; FR 92140
• Manufacturer (Section G): SORIN GROUP ITALIA SRL VIA CRESCENTINO 13040 SALUGGIA ITALY; parc d'affaires noveos 4 avenue réaumur; .; clamart 9214 0; FR 92140
• Manufacturer Contact: elodie vincent ; parc d'affaires noveos 4 avenue réaumur; .; clamart 92140 ; FR 92140 ; 0146013665
• MDR Report Key: 4361362
• MDR Text Key: 5286088
• Report Number: 1000165971-2014-00726
• Device Sequence Number: 1
• Product Code: NVZ
• Combination Product (y/n): N
• Reporter Country Code: CA
• PMA/PMN Number: PP950029
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date: 12/05/2014

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: 09/17/2013
• Device Model Number: REPLY DR
• Device Catalogue Number: REPLY DR
• Device Lot Number: 2616
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Distributor Facility Aware Date: 12/05/2014
• Initial Date Manufacturer Received: 02/20/2015
• Initial Date FDA Received: 12/24/2014
• Supplement Dates Manufacturer Received: Not provided; Not provided
• Supplement Dates FDA Received: 02/16/2015; 02/20/2015
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 05/11/2012
• 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