MAUDE Adverse Event Report: MANUFACTURED FOR MICROPORT CRM S.R.L. SMARTTOUCH; PROGRAMMER, PACEMAKER

Model Number SMARTTOUCH CPR3H

Device Problem Interrogation Problem (4017)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 07/28/2020

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 sorin that was cleared or approved by fda for marketing in the united states.

Event Description

Reportedly, when interrogating a paradym vr device, the error message 'interrogation impossible' was displayed with the following suggestions: end the session and try to interrogate the device again.If the previous point does not work, use the emergency programming.Contact your sorin representative.It was still impossible to interrogate the implant after several tests and by trying the suggested methods.However, successful interrogation could be conducted with an orchestra plus programmer.After the follow-up, a new attempt to interrogate the icd with the associated tablet could be performed without issue.It should be noted that a week earlier, the tablet remained blocked and inoperable leading to a restart by battery removal.

Event Description

Reportedly, when interrogating a paradym vr device, the error message 'interrogation impossible' was displayed with the following suggestions: end the session and try to interrogate the device again.If the previous point does not work, use the emergency programming.Contact your sorin representative.It was still impossible to interrogate the implant after several tests and by trying the suggested methods.However, successful interrogation could be conducted with an orchestra plus programmer.After the follow-up, a new attempt to interrogate the icd with the associated tablet could be performed without issue.It should be noted that a week earlier, the tablet remained blocked and inoperable leading to a restart by battery removal.

• Brand Name: SMARTTOUCH
• Type of Device: PROGRAMMER, PACEMAKER
• Manufacturer (Section D): MANUFACTURED FOR MICROPORT CRM S.R.L.; parc d'affaires noveos 4 avenue réaumur; clamart, 92140 ; FR
• MDR Report Key: 10437521
• MDR Text Key: 204195851
• Report Number: 1000165971-2020-00564
• Device Sequence Number: 1
• Product Code: KRG
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Type of Report: Initial,Followup
• Report Date: 10/30/2020

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 Model Number: SMARTTOUCH CPR3H
• Device Catalogue Number: SMARTTOUCH CPR3H
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/17/2020
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 07/28/2020
• Event Location: Hospital
• Initial Date Manufacturer Received: 07/28/2020
• Initial Date FDA Received: 08/21/2020
• Supplement Dates Manufacturer Received: 10/16/2020
• Supplement Dates FDA Received: 10/30/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1