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

Model Number REPLY DR

Device Problem Interrogation Problem (4017)

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

Event Date 12/02/2020

Event Type  Injury  

Event Description

Reportedly, the pacemaker could not be interrogated after two cardioversion procedures at 150 joules and 200 joules.The device was implanted on the right side of the patient and the defribillation patch was also positioned on the right side of the patient.The device was explanted and should be returned for anlaysis.

Event Description

Reportedly, the pacemaker could not be interrogated after two cardioversion procedures at 150 joules and 200 joules.The device was implanted on the right side of the patient and the defibrillation patch was also positioned on the right side of the patient.The device was explanted and should be returned for analysis.

• 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: 11073329
• MDR Text Key: 223705306
• Report Number: 1000165971-2020-00848
• Device Sequence Number: 1
• Product Code: NVZ
• Combination Product (y/n): N
• PMA/PMN Number: P950029
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Type of Report: Initial,Followup
• Report Date: 04/02/2021

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: 07/09/2015
• Device Model Number: REPLY DR
• Device Catalogue Number: REPLY DR
• Device Lot Number: 2789
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/06/2021
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 12/07/2020
• Initial Date Manufacturer Received: 12/07/2020
• Initial Date FDA Received: 12/24/2020
• Supplement Dates Manufacturer Received: 03/08/2021
• Supplement Dates FDA Received: 04/02/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention