MAUDE Adverse Event Report: MicroPort CRM S.r.l. CPR4; Pacemaker/Icd/Crt Non-Implanted Components

Model Number	CPR4 HEAD
Medical Device Problem Code	Crack (1135)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/10/2026
Type of Reportable Event	Malfunction
Event or Problem Description
Increased cracking at the corners around the attachment points, along with a malfunction of one of the four white leds.
Additional Manufacturer Narrative
Upon receipt, the reported behavior was confirmed: the subject cpr4 is no longer functional.The cpr4 is cracked on both sides of the upper shell.The most probable hypothesis is that a fall on a hard surface caused the cracks on the plastic parts.No general malfunction is suspected with the subject device.This case is retained and utilized for trend purposes.

• Brand Name: CPR4
• Common Device Name: Pacemaker/Icd/Crt Non-Implanted Components
• 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: 50802851
• Report Number: 1000165971-2026-01099
• Device Sequence Number: 20968156
• Product Code: OSR
• UDI-Device Identifier: 08031527019611
• UDI-Public: (01)08031527019611(17)070607
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• PMA/510(K) Number: P980049
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 09/17/2026

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
• Operator of Device: Health Professional
• Device Model Number: CPR4 HEAD
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 09/17/2026
• Is the Reporter a Health Professional?: Yes
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 09/17/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown