MAUDE Adverse Event Report: MICROPORT CRM S.R.L. VEGA; DRUG ELUTING PERMANENT RIGHT VENTRICULAR (RV) OR RIGHT ATRIAL (RA) PACEMAKER ELE

Model Number VEGA R52

Device Problem Material Deformation (2976)

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

Event Date 08/31/2023

Event Type  malfunction  

Event Description

Reportedly, when retrieving the lead for implantation, (b)(6) noticed that the screw was already extended in the lead box.He decided to take the lead out of its packaging and try to insert the screw into the lead body, but without success.He therefore decided not to implant the lead.

Manufacturer Narrative

Investigation summary: a review of the manufacturing records did not present any irregularities during the final packaging inspection process relative to the subject device.It should be noted that with such an irregularity on the lead, the product would have not been released for distribution.Based on the information provided, when the lead was received, the screw was slightly protruding from the tooth, which was probably due to the transport (and vibrations) that affected the lead and caused the screw to extend slightly.When the physician attempted to repair the lead (which explains that the body of the lead was wrinkled and the presence of blood traces near the distal ring and on the stylet), it most likely resulted in further damage to the lead, with the result that the screw received for the investigation was completely out of the core tip and bent.It should be noted that despite this very slight protrusion of the screw, these leads could have been implanted.

Event Description

Reportedly, when retrieving the lead for implantation, dr.Napporn noticed that the screw was already extended in the lead box.He decided to take the lead out of its packaging and try to insert the screw into the lead body, but without success.He therefore decided not to implant the lead.

• Brand Name: VEGA
• Type of Device: DRUG ELUTING PERMANENT RIGHT VENTRICULAR (RV) OR RIGHT ATRIAL (RA) PACEMAKER ELE
• 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: elodie vincent ; via crescentino s.n; saluggia (vc) 13040 ; IT 13040 ; 146013665
• MDR Report Key: 17772074
• MDR Text Key: 323684407
• Report Number: 1000165971-2023-00736
• Device Sequence Number: 1
• Product Code: NVN
• Combination Product (y/n): N
• Reporter Country Code: FR
• PMA/PMN Number: P130010
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional
• Reporter Occupation: Physician
• Remedial Action: Replace
• Type of Report: Initial,Followup
• Report Date: 10/27/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/19/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: VEGA R52
• Device Catalogue Number: VEGA R52
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/13/2023
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 10/06/2023
• Was Device Evaluated by Manufacturer?: Yes
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Ethnicity: Non Hispanic