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

Model Number REPLY DR

Device Problem Pacing Intermittently (1443)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 02/19/2021

Event Type  malfunction  

Event Description

During a replacement procedure due to normal battery depletion of the subject pacemaker, a temporary lead for a patient without intrinsic beat was inserted before the intervention.At that time, ecg waveforms that seem to be a ventricular pacing failure were observed on the monitor.The pacemaker was checked, but the event was not reproduced.Since the measurement data of the pacemaker was the same as before, the pacemaker replacement intervention was completed.However, since the cause could not be identified, it was still decided to follow up in the ward with the temporary lead inserted even after the replacement.The physician requested an analysis of the subject pacemaker.

Event Description

During a replacement procedure due to normal battery depletion of the subject pacemaker, a temporary lead for a patient without intrinsic beat was inserted before the intervention.At that time, ecg waveforms that seem to be a ventricular pacing failure were observed on the monitor.The pacemaker was checked, but the event was not reproduced.Since the measurement data of the pacemaker was the same as before, the pacemaker replacement intervention was completed.However, since the cause could not be identified, it was still decided to follow up in the ward with the temporary lead inserted even after the replacement.The physician requested an analysis of the subject pacemaker.

• 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: laura ouaki ; via crescentino s.n.; saluggia (vc), 13040 ; IT 13040
• MDR Report Key: 11552246
• MDR Text Key: 242075548
• Report Number: 1000165971-2021-00359
• 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
• Report Date: 05/10/2021

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: 02/04/2014
• Device Model Number: REPLY DR
• Device Catalogue Number: REPLY DR
• Device Lot Number: 2632
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/24/2021
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 02/26/2021
• Initial Date FDA Received: 03/23/2021
• Supplement Dates Manufacturer Received: 04/13/2021
• Supplement Dates FDA Received: 05/12/2021
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 07/04/2012
• 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