MAUDE Adverse Event Report: MICROPORT CRM S.R.L. SMARTTOUCH SOFTWARES MODULES; KRG - PROGRAMMER, PACEMAKER

Model Number SMARTTOUCH SOFTWARES MODULES

Device Problem Wireless Communication Problem (3283)

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

Event Date 11/02/2023

Event Type  malfunction  

Event Description

Reportedly, after several attempts it is not possible to interrogate an pacemaker with bluetooth wireless telemetry, the following error message "rf communication disabled" appears.With another programmer, the same pacemaker can be interrogated with wireless telemetry without problems.

Manufacturer Narrative

Following the analysis, the device was corrected by software modules (d1, d4) - files analysis revealed that the bluetooth adapter was unexpectedly deactivated, which led to the observed difficulties to use ble communication with an alizea pacemaker.- it should be noted that re-installing smartview 3.12 version on the programmer should solve the observed issue.

Event Description

Reportedly, after several attempts it is not possible to interrogate an pacemaker with bluetooth wireless telemetry, the following error message "rf communication disabled" appears.With another programmer, the same pacemaker can be interrogated with wireless telemetry without problems.

• Brand Name: SMARTTOUCH SOFTWARES MODULES
• Type of Device: KRG - PROGRAMMER, PACEMAKER
• Manufacturer (Section D): MICROPORT CRM S.R.L.; via crescentino s.n; 4 avenue reaumur; 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 ; 146013665
• MDR Report Key: 18208211
• MDR Text Key: 328963762
• Report Number: 1000165971-2023-00973
• Device Sequence Number: 1
• Product Code: KRG
• Combination Product (y/n): N
• Reporter Country Code: SP
• PMA/PMN Number: P980049
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Company Representative
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 12/22/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/27/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: SMARTTOUCH SOFTWARES MODULES
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 11/28/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Ethnicity: Non Hispanic