MAUDE Adverse Event Report: MICROPORT CRM S.R.L. BOREA; PULSE GENERATOR, PERMANENT, IMPLANTABLE

Model Number BOREA SR 1200

Device Problem Packaging Problem (3007)

Patient Problem Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)

Event Date 12/22/2022

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.A review of the manufacturing records did not present any irregularities during the final packaging inspection process.It should be noted that with such an irregularity on the external packaging, the products would have not been released for distribution.Therefore, it is concluded that the observed issue was most probably generated during transportation.Corrective actions are on-going in order to reduce the occurrence of packaging damaged during the whole transportation cycle.

Event Description

Reportedly, on december 22th, a shipment from saluggia was received to barcelona whs, order 4600063519 and dn 4100569534.During the visual inspection of the received devices (shipping list attached), the local whs personnel observed the following two (2) devices in bad conditions: borea sr 1200, sn 104ge04e, the cardboard outer packaging was totally unsealed, kora 250 dr, sn 231be3c7, with the corner knocked (pictures attached).The transport carton box showing that the corner is knocked too.

• Brand Name: BOREA
• Type of Device: PULSE GENERATOR, PERMANENT, IMPLANTABLE
• 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: 16172790
• MDR Text Key: 307998974
• Report Number: 1000165971-2023-00021
• Device Sequence Number: 1
• Product Code: NVZ
• Combination Product (y/n): N
• Reporter Country Code: SP
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 01/16/2023

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 Operator: Health Professional
• Device Model Number: BOREA SR 1200
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 12/22/2022
• Initial Date FDA Received: 01/16/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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