MAUDE Adverse Event Report: MicroPort CRM S.r.l. HookUp; Programmer, Pacemaker

Model Number	HookUp Smart
Medical Device Problem Code	Incorrect Measurement (1383)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/01/2026
Type of Reportable Event	Malfunction
Event or Problem Description
Reportedly, during lbbot case in hospital (b)(6) in (b)(6), v6-v1 could never be measured, as v1 was always negative.Also, there was v6wrpt measurement since the very placement of the leads, even before the physicians started to operate.After contacting and discusing with the spanish clinical team, already experienced in the use of lbbot in the clinical phase, the hypothesis was that qrs from lead iii was so sharp that it was being detected as a spike.Then, after changing spike detection channel to either i or v1, the spike detection and the measurements stopped.
Additional Manufacturer Narrative
Analysis synthesis: review of the software analysis confirmed the reported behavior during the lbbot procedure, with spontaneous qrs complexes incorrectly detected as pacing spikes, leading to inappropriate measurements.The investigation showed that a specific qrs morphology on lead iii (narrow, high-amplitude qrs) generated sufficient high-frequency content to exceed the spike detection threshold.As a result, the software classified these signals as spikes, although no actual pacing spikes were present.This behavior is consistent with the current system specifications.The issue was attributed to the software spike detection algorithm and not to any smart ecg hardware malfunction.No patient safety risk or cybersecurity concern was identified during the investigation.This case will be retained for trending and monitoring purposes.

• Brand Name: HookUp
• Common Device Name: Programmer, Pacemaker
• 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: anne rousseau-plasse ; via crescentino s.n; saluggia (vc) 13040 ; IT 13040 ; +33(146)013082
• MDR Report Key: 50153020
• Report Number: 1000165971-2026-04080
• Device Sequence Number: 13413675
• Product Code: KRG
• Combination Product (Y/N): N
• Initial Reporter Country: SP
• PMA/510(K) Number: P980049-S137
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 08/06/2026

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 Model Number: HookUp Smart
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 08/06/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Patient Sequence Number: 1
• Patient Sex: Unknown