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 Problems Capturing Problem (2891); Device Sensing Problem (2917); Device Dislodged or Dislocated (2923); Impedance Problem (2950)

Patient Problem Cramp(s) /Muscle Spasm(s) (4521)

Event Date 02/14/2024

Event Type  malfunction  

Event Description

Reportedly, the vega r52 lead was implanted on (b)(6) 2024.Over the course of the week the patient noticed muscular convulsions.Afterwards a clinical pm follow up was initiated.The clinical patient examination and the measurement values (sensing / impedance / threshold) indicated a lead dislodgement.Afterwards it was decided to perform an atrial lead revision.During lead revision it was not possible to fix the already implanted vega r52 lead again in the atrial tissue.Therefore another vega r52 lead was implanted.

Manufacturer Narrative

Summary of the investigation: review of the associated manufacturing record revealed no evidence of inconsistency during the manufacturing process that could be related to the reported issue.The lead was returned cut in two distinct parts, certainly due to a difficult explantation procedure and neither dimensional nor mechanical tests could be performed.The x-rays performed on the returned subject lead confirm that the inner coil and the screw mechanism were free from any damages that could lead to the reported event: lead dislodgement.According to the patient files provided good electrical measurements within normal range were obtained during at the implantation and at the one-week in-clinic follow-up.The detailed data are not available in the provided patient files.Based on available information, and since no x-ray of the lead positioning was provided, the reported dislodgement could not be confirmed with certainly.Lead dislodgement most likely occurred due to external factors that are independent of the lead characteristics, such as physician preferred implant site or patient physiology/anatomy.These issues are well-known potential complications associated to such implantable devices that are discussed in the device instructions-for-use and published literature.This case is retained and utilized for trending purposes.For more details, please refer to the enclosed report analysis.

Event Description

Reportedly, the vega r52 lead was implanted on (b)(6) 2024.Over the course of the week the patient noticed muscular convulsions.Afterwards a clinical pm follow up was initiated.The clinical patient examination and the measurement values (sensing / impedance / threshold) indicated a lead dislodgement.Afterwards it was decided to perform an atrial lead revision.During lead revision it was not possible to fix the already implanted vega r52 lead again in the atrial tissue.Therefore another vega r52 lead was implanted.

• 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: 18903108
• MDR Text Key: 337651035
• Report Number: 1000165971-2024-00220
• Device Sequence Number: 1
• Product Code: NVN
• UDI-Device Identifier: 08031527016603
• UDI-Public: (01)08031527016603(17)260826
• Combination Product (y/n): N
• Reporter Country Code: SZ
• PMA/PMN Number: P130010
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 05/24/2024

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?: No
• Device Operator: Health Professional
• Device Model Number: VEGA R52
• Device Catalogue Number: TLD041C
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 02/14/2024
• Initial Date FDA Received: 03/14/2024
• Supplement Dates Manufacturer Received: 05/24/2024
• Supplement Dates FDA Received: 05/24/2024
• 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