MAUDE Adverse Event Report: MICROPORT CRM S.R.L. ENO; IMPLANTABLE PULSE GENERATOR, PACEMAKER (NON-CRT)

Model Number ENO DR

Device Problem Device Markings/Labelling Problem (2911)

Patient Problem No Patient Involvement (2645)

Event Date 10/02/2020

Event Type  malfunction  

Manufacturer Narrative

The device involved in this mdr report is not approved in the united states; however, it is similar to a device manufactured by microport crm that was cleared or approved by fda for marketing in the united states.

Event Description

Reportedly, the information printed on patient stickers was not aligned with the sticker size.

Manufacturer Narrative

Summary of the investigation: review of the manufacturing records confirmed that the labels were incorrectly printed following the automated packaging method.The root cause of this irregularity is attributed to a misalignment between the sticker template and the printer variability: the size of the printed content is slightly smaller than the size indicated in the specifications.In addition, the initial positioning of the label roll in the printer can contribute to the acceleration of the observed misalignment.Due to these printing variabilities, the alignment of the stickers is slightly affected during the print session as the number of labels remaining in the printer label roll decreases.The devices in stock showing a similar behavior were reworked to correct this issue.In order to avoid the reoccurrence of such issue, a corrective action was launched to update the patient sticker label templates and its validation process, and to update the automated visual inspection to verify the alignment of these patient stickers.It should be noted that there is no patient safety risk associated to this nonconformance.The investigation results are retained and utilized for trending purposes.

Event Description

Reportedly, the information printed on patient stickers was not aligned with the sticker size.

• Brand Name: ENO
• Type of Device: IMPLANTABLE PULSE GENERATOR, PACEMAKER (NON-CRT)
• Manufacturer (Section D): MICROPORT CRM S.R.L.; via crescentino s.n.; saluggia (vc) 13040 ; IT 13040
• MDR Report Key: 10725025
• MDR Text Key: 214541813
• Report Number: 1000165971-2020-00665
• Device Sequence Number: 1
• Product Code: LWP
• UDI-Device Identifier: 08031527017181
• UDI-Public: (01)08031527017181(11)200619(17)220619
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative
• Type of Report: Initial,Followup
• Report Date: 12/17/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/23/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 06/19/2022
• Device Model Number: ENO DR
• Device Catalogue Number: ENO DR
• Device Lot Number: S0453
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 10/02/2020
• Date Manufacturer Received: 11/25/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1