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

Model Number REPLY VDR

Device Problems Failure to Capture (1081); Over-Sensing (1438); Failure to Sense (1559); Low impedance (2285)

Patient Problems No Information (3190); No Clinical Signs, Symptoms or Conditions (4582)

Event Date 01/14/2021

Event Type  malfunction  

Manufacturer Narrative

The device involved in this mdr report is not approved in the united states; however, it is similar to a device manufactured by microport crm that was cleared or approved by fda for marketing in the united states.

Event Description

The pacing system was implanted on (b)(6) 2019 to a patient with a complete av block.Reportedly, during a follow-up performed in (b)(6) 2020, a decrease of the lead impedance to 205 ohms was observed.Episodes showing noise on the atrial channel were recorded in the device memory.The pacing mode regularly switched in vvi.In addition, ventricular events were not detected.Though the sensitivity was programmed to the maximum value, failure to sense was observed.The capture threshold was measured at 1.0 v.X-ray images did not reveal any lead issue or dislodgement.A re-intervention was scheduled to check the pacing system.When unscrewing the leads during a re-intervention performed in (b)(6) 2020, blood traces were observed in both connector cavities.After cleaning the traces of blood, pacing system analyzer (psa) measurements were performed for the atrioventricular lead but no anomaly was found.The ventricular measurements showed a good r-wave detection (5-8 mv), lead impedance measurements were within normal range (350-400 ohms) and the ventricular capture threshold was at 0,6v/0,4ms.The atrial measurements showed a good p-wave detection (0,5-0,6 mv).Therefore, the lead was re-connected to the pacemaker and re-inserted in the pocket.During a follow-up performed on (b)(6) 2021, the same issue was observed.The lead impedance decreased to 215 ohms and loss of atrial capture was observed.The pacing mode regularly switched in vvi.However, ventricular events were not detected, even though the patient escape rhythm was 30 bpm.A lead and/or connection issue were suspected by the physician, who scheduled a re-intervention.On (b)(6) 2021, the pacemaker was replaced, and the lead was abandoned in patient¿s body.Preliminary analysis revealed that the observed issue most probably resulted from an atrioventricular lead issue and/or lead-pacemaker connection issues at atrial and ventricular levels.

Manufacturer Narrative

Please refer to the attached analysis report.

Event Description

The pacing system was implanted on (b)(6) 2019 to a patient with a complete av block.Reportedly, during a follow-up performed in (b)(6) 2020, a decrease of the lead impedance to 205 ohms was observed.Episodes showing noise on the atrial channel were recorded in the device memory.The pacing mode regularly switched in vvi.In addition, ventricular events were not detected.Though the sensitivity was programmed to the maximum value, failure to sense was observed.The capture threshold was measured at 1.0 v.X-ray images did not reveal any lead issue or dislodgement.A re-intervention was scheduled to check the pacing system.When unscrewing the leads during a re-intervention performed in (b)(6) 2020, blood traces were observed in both connector cavities.After cleaning the traces of blood, pacing system analyzer (psa) measurements were performed for the atrioventricular lead but no anomaly was found.The ventricular measurements showed a good r-wave detection (5-8 mv), lead impedance measurements were within normal range (350-400 ohms) and the ventricular capture threshold was at 0,6v/0,4ms.The atrial measurements showed a good p-wave detection (0,5-0,6 mv).Therefore, the lead was re-connected to the pacemaker and re-inserted in the pocket.During a follow-up performed on (b)(6) 2021, the same issue was observed.The lead impedance decreased to 215 ohms and loss of atrial capture was observed.The pacing mode regularly switched in vvi.However, ventricular events were not detected, even though the patient escape rhythm was 30 bpm.A lead and/or connection issue were suspected by the physician, who scheduled a re-intervention.On (b)(6) 2021, the pacemaker was replaced, and the lead was abandoned in patient's body.Preliminary analysis revealed that the observed issue most probably resulted from an atrioventricular lead issue and/or lead-pacemaker connection issues at atrial and ventricular levels.

• 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
• MDR Report Key: 11320306
• MDR Text Key: 233744849
• Report Number: 1000165971-2021-00279
• Device Sequence Number: 1
• Product Code: NVZ
• UDI-Device Identifier: 08031527008950
• UDI-Public: (01)08031527008950(11)190731(17)210228
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Type of Report: Initial,Followup
• Report Date: 06/04/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 02/28/2021
• Device Model Number: REPLY VDR
• Device Catalogue Number: REPLY VDR
• Device Lot Number: S0395
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/03/2021
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 01/19/2021
• Event Location: Hospital
• Initial Date Manufacturer Received: 01/19/2021
• Initial Date FDA Received: 02/12/2021
• Supplement Dates Manufacturer Received: 05/14/2021
• Supplement Dates FDA Received: 06/04/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1