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

Model Number REPLY DR

Device Problem Connection Problem (2900)

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

Event Date 08/17/2017

Event Type  Injury  

Event Description

Reportedly during a pacemaker replacement, the connector pins of two is-1 leads were found to be stuck in the atrial and ventricular ports of the subject pacemaker after 7 years of connection.After both of the atrial and ventricular set-screws were loosened, the physician attempted to pull out the leads from the ports; then, on each lead, the coils in the lead connector area extended while the connector pin was still inside the port.After the physician removed the silicone cover and the set-screws of the pacemaker to try to move the connector pins directly, both leads were eventually pulled out from the ports by force (since the leads were already unusable due to the extension of the coils).

Event Description

Reportedly during a pacemaker replacement, the connector pins of two is-1 leads were found to be stuck in the atrial and ventricular ports of the subject pacemaker after 7 years of connection.After both of the atrial and ventricular set-screws were loosened, the physician attempted to pull out the leads from the ports; then, on each lead, the coils in the lead connector area extended while the connector pin was still inside the port.After the physician removed the silicone cover and the set-screws of the pacemaker to try to move the connector pins directly, both leads were eventually pulled out from the ports by force (since the leads were already unusable due to the extension of the coils).

Manufacturer Narrative

Preliminary analysis showed that the magnet rate and some impulse amplitudes were out of specification, which is probably due to the implantation life of device (7 years).Other electrical characteristics were within specification.The connection system functions as specified.However, the device was returned without the silicone cover and the screws were out of the connection blocks.No tightening mark was found on atrial screw, and the first thread was damaged.

Event Description

Reportedly during a pacemaker replacement, the connector pins of two is-1 leads were found to be stuck in the atrial and ventricular ports of the subject pacemaker after 7 years of connection.After both of the atrial and ventricular set-screws were loosened, the physician attempted to pull out the leads from the ports; then, on each lead, the coils in the lead connector area extended while the connector pin was still inside the port.After the physician removed the silicone cover and the set-screws of the pacemaker to try to move the connector pins directly, both leads were eventually pulled out from the ports by force (since the leads were already unusable due to the extension of the coils).

• 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: 6829508
• MDR Text Key: 83939055
• Report Number: 1000165971-2017-00697
• Device Sequence Number: 1
• Product Code: NVZ
• Combination Product (y/n): N
• Reporter Country Code: JA
• 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,Followup,Followup
• Report Date: 08/21/2017

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: 11/23/2011
• Device Model Number: REPLY DR
• Device Catalogue Number: REPLY DR
• Device Lot Number: 2448
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/12/2017
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 08/21/2017
• Event Location: Hospital
• Initial Date Manufacturer Received: 08/21/2017
• Initial Date FDA Received: 08/30/2017
• Supplement Dates Manufacturer Received: 09/29/2017; 11/28/2017
• Supplement Dates FDA Received: 10/27/2017; 12/20/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 04/23/2017
• 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