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

Model Number ESPRIT S

Device Problem Loss of Threshold (1633)

Patient Problem Bradycardia (1751)

Event Date 06/16/2015

Event Type  malfunction  

Event Description

Reportedly, the patient went to the emergency room on (b)(6) 2015 presenting bradycardia and asystolic periods (ecg showed ventricular capture loss).A pacemaker follow-up was performed.An alert was displayed in overview showing a lead impedance above 3000 ohms.The physician tested the lead impedance manually and the value remained above 3000 ohms.The ventricular threshold was tested and no capture was possible to achieve, even with 7,5v@1.00ms.In the previous follow-ups the impedance was around 500 ohms, sensing above 15mv and the threshold was stable at 0,75v.On the (b)(6) 2015, the patient went to a re-intervention and the ventricular lead was tested using a psa.The measurements with the psa were unstable.The subject lead was extracted and a new lead (non-sorin) was implanted.Since it was very difficult to remove the entire lead body (adherence to the veins) the proximal lead body was cut and collected to vigilance.After implanting the new lead, the connection between the lead and the can was also unstable (intermittent pacing).The physician decided to replace the device.The subject device will be returned for analysis.

Manufacturer Narrative

The device model involved in this mdr report is not approved in the u.S.; however, it is similar to reply dr or sr models approved under p950029.

Event Description

Reportedly, the patient went to the emergency room on (b)(6) 2015 presenting bradycardia and asystolic periods (ecg showed ventricular capture loss).A pacemaker follow-up was performed.An alert was displayed in overview showing a lead impedance above 3000 ohms.The physician tested the lead impedance manually and the value remained above 3000 ohms.The ventricular threshold was tested and no capture was possible to achieve, even with 7,5v@1.00ms.In the previous follow-ups the impedance was around 500 ohms, sensing above 15mv and the threshold was stable at 0,75v.On the (b)(6) 2015 the patient went to a re-intervention and the ventricular lead was tested using a psa.The measurements with the psa were unstable.The subject lead was extracted and a new lead (non-sorin) was implanted.Since it was very difficult to remove the entire lead body (adherence to the veins) the proximal lead body was cut and collected to vigilance.After implanting the new lead, the connection between the lead and the can was also unstable (intermittent pacing).The physician decided to replace the device.The subject device will be returned for analysis.

Manufacturer Narrative

Preliminary analysis of the returned device did not reveal any anomaly.

Event Description

Reportedly, the patient went to the emergency room on (b)(6) 2015 presenting bradycardia and assistolic periods (ecg showed ventricular capture loss).A pacemaker follow-up was performed.An alert was displayed in overview showing a lead impedance above 3000 ohms.The physician tested the lead impedance manually and the value remained above 3000 ohms.The ventricular threshold was tested and no capture was possible to achieve, even with 7,5v@1.00ms.In the previous follow-ups the impedance was around 500 ohms, sensing above 15mv and the threshold was stable at 0,75v.On the (b)(6) 2015 the patient went to a re-intervention and the ventricular lead was tested using a psa.The measurements with the psa were unstable.The subject lead was extracted and a new lead (non-sorin) was implanted.Since it was very difficult to remove the entire lead body (adherence to the veins) the proximal lead body was cut and collected to vigilance.After implanting the new lead, the connection between the lead and the can was also unstable (intermittent pacing).The physician decided to replace the device.The subject device will be returned for analysis.

• 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: 4918920
• MDR Text Key: 19004057
• Report Number: 1000165971-2015-00430
• Device Sequence Number: 1
• Product Code: NVZ
• Combination Product (y/n): N
• Reporter Country Code: PO
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Invalid Data,health professional
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 06/17/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/16/2015
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 06/22/2012
• Device Model Number: ESPRIT S
• Device Catalogue Number: ESPRIT S
• Device Lot Number: 2501
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/02/2015
• Is the Reporter a Health Professional?: Yes
• Distributor Facility Aware Date: 06/17/2015
• Date Manufacturer Received: 09/25/2015
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 11/22/2010
• 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