MAUDE Adverse Event Report: MICROPORT CRM S.R.L. REPLY; PULSE GENERATOR, PERMANENT, IMPLANTABLE

Model Number REPLY DR

Device Problem Material Integrity Problem (2978)

Patient Problem Insufficient Information (4580)

Event Date 03/22/2021

Event Type  Injury  

Event Description

Reportedly, the subject pacemaker was implanted on (b)(6) 2011 to treat an avb.The patient was hospitalized from (b)(6) to (b)(6) 2021 to replace the pacemaker and leads, which were not operating correctly.During the previous follow-ups, a dysfunction of the atrial lead was observed (increase of the lead impedance and loss of capture), then a similar issue was observed on the ventricular lead.The ecg performed before the re-intervention was normal (sinus rhythm, with normal pr interval, avb).On (b)(6) 2021, upon explantation of the pacemaker, a complete fracture of the header was observed, explaining the dysfunctioning of the leads.The leads were tested with a psa.Proper operation of the leads was observed with thresholds below 1v.As a result, the leads were kept implanted and connected to a new pacemaker.

Manufacturer Narrative

Preliminary of analysis of the returned device showed that its header was detached from the can.

Event Description

Reportedly, the subject pacemaker was implanted on (b)(6) 2011 to treat an avb.The patient was hospitalized from (b)(6) 2021 to replace the pacemaker and leads, which were not operating correctly.During the previous follow-ups, a dysfunction of the atrial lead was observed (increase of the lead impedance and loss of capture), then a similar issue was observed on the ventricular lead.The ecg performed before the re-intervention was normal (sinus rhythm, with normal pr interval, avb).On (b)(6) 2021, upon explantation of the pacemaker, a complete fracture of the header was observed, explaining the dysfunctioning of the leads.The leads were tested with a psa.Proper operation of the leads was observed with thresholds below 1v.As a result, the leads were kept implanted and connected to a new pacemaker.It should be noted that the patient suffered a fracture in 2015.Preliminary analysis of the available patient files showed unstable and high ventricular lead impedances (in the order of 3000 ohms) since (at least) (b)(6) 2020.Loss of ventricular capture was observed in the real time test from (b)(6) 2021.Episodes with non-physiological signals were noted in both channels since (at least) (b)(6) 2021.An intermittent behavior was identified relative to the ventricular channel.

Manufacturer Narrative

B5 updated.H6 (type of investigation) updated.Review of the device history records showed no anomaly.

Event Description

Reportedly, the subject pacemaker was implanted on (b)(6) 2011 to treat an avb.The patient was hospitalized from (b)(6) 2021 to replace the pacemaker and leads, which were not operating correctly.During the previous follow-ups, a dysfunction of the atrial lead was observed (increase of the lead impedance and loss of capture), then a similar issue was observed on the ventricular lead.The ecg performed before the re-intervention was normal (sinus rhythm, with normal pr interval, avb).On (b)(6) 2021, upon explantation of the pacemaker, a complete fracture of the header was observed, explaining the dysfunctioning of the leads.The leads were tested with a psa.Proper operation of the leads was observed with thresholds below 1v.As a result, the leads were kept implanted and connected to a new pacemaker.It should be noted that the patient suffered a fracture in 2015.Preliminary analysis of the available patient files showed unstable and high ventricular lead impedances (in the order of 3000 ohms) since (at least) (b)(6) 2020.Loss of ventricular capture was observed in the real time test from (b)(6) 2021.Episodes with non-physiological signals were noted in both channels since (at least) (b)(6) 2021.An intermittent behavior was identified relative to the ventricular channel.

Event Description

Reportedly, the subject pacemaker was implanted on (b)(6) 2011 to treat an avb.The patient was hospitalized from (b)(6) 2021 to replace the pacemaker and leads, which were not operating correctly.During the previous follow-ups, a dysfunction of the atrial lead was observed (increase of the lead impedance and loss of capture), then a similar issue was observed on the ventricular lead.The ecg performed before the re-intervention was normal (sinus rhythm, with normal pr interval, avb).On (b)(6) 2021, upon explantation of the pacemaker, a complete fracture of the header was observed, explaining the dysfunctioning of the leads.The leads were tested with a psa.Proper operation of the leads was observed with thresholds below 1v.As a result, the leads were kept implanted and connected to a new pacemaker.It should be noted that the patient suffered a fracture in the tibia in 2015.Preliminary analysis of the available patient files showed unstable and high ventricular lead impedances (in the order of 3000 ohms) since (at least) (b)(6) 2020.Loss of ventricular capture was observed in the real time test from (b)(6) 2021.Episodes with non-physiological signals were noted in both channels since (at least) (b)(6) 2021.An intermittent behavior was identified relative to the ventricular channel.

Manufacturer Narrative

B5 updated.Please refer to the attached analysis report.

• Brand Name: REPLY
• Type of Device: PULSE GENERATOR, PERMANENT, IMPLANTABLE
• Manufacturer (Section D): MICROPORT CRM S.R.L.; via crescentino s.n.; saluggia (vc), 13040 ; IT 13040
• Manufacturer (Section G): MICROPORT CRM S.R.L.; via crescentino s.n.; saluggia (vc), 13040 ; IT 13040
• Manufacturer Contact: elodie vincent ; via crescentino s.n.; saluggia (vc), 13040 ; IT 13040
• MDR Report Key: 12525213
• MDR Text Key: 273088251
• Report Number: 1000165971-2021-00654
• Device Sequence Number: 1
• Product Code: NVZ
• Combination Product (y/n): N
• Reporter Country Code: FR
• PMA/PMN Number: P950029
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other
• Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup,Followup
• Report Date: 01/19/2022

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: 01/28/2013
• Device Model Number: REPLY DR
• Device Catalogue Number: REPLY DR
• Device Lot Number: 2549
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/26/2021
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 08/31/2021
• Initial Date FDA Received: 09/24/2021
• Supplement Dates Manufacturer Received: 10/19/2021; 12/06/2021; 01/13/2022
• Supplement Dates FDA Received: 11/12/2021; 12/21/2021; 01/19/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 06/28/2011
• 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