MAUDE Adverse Event Report: MPRI SENSIGHT

Model Number B3400060M

Device Problem Component Missing (2306)

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

Event Date 12/15/2021

Event Type  malfunction  

Event Description

It was reported that the patient had both stage 1 and 2 surgeries performed today. the extension was opened and successfully tunneled.Upon attempting to screw the lead into the extension, it was seen that there was no screw present in the screw port.A backup screw was opened from the extension box and was placed successfully.The surgery was completed with no further difficulties.There were no environmental/external/patient factors noted that may have led or contributed to the issue. the sterile package was searched for the missing screw but it was not found.The scrub stated she did not think it fell out at any point.The surgeon and scrub thinks it simply was not in the extension.The issue was resolved.There was no harm to the patient.

Manufacturer Narrative

If information is provided in the future, a supplemental report will be issued.

Event Description

Additional information received from the manufacturer¿s representative (rep) reported the missing setscrew was the one in the extension itself.The extra setscrew that came in the small plastic bag was present and used to replace the missing one in the extension itself.

Manufacturer Narrative

If information is provided in the future, a supplemental report will be issued.

• Brand Name: SENSIGHT
• Manufacturer (Section D): MPRI; road 149 km 56.3; villalba PR 00766
• Manufacturer (Section G): MPRI; road 149 km 56.3; villalba PR 00766
• Manufacturer Contact: glen belmer ; 7000 central avenue ne rcw215; minneapolis, MN 55432 ; 6122713209
• MDR Report Key: 13029200
• MDR Text Key: 282492532
• Report Number: 2649622-2021-25108
• Device Sequence Number: 1
• Product Code: MHY
• UDI-Device Identifier: 00763000426484
• UDI-Public: 00763000426484
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P960009
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Company Representative
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date: 01/05/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/17/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 11/11/2023
• Device Model Number: B3400060M
• Device Catalogue Number: B3400060M
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 12/23/2021
• Date Device Manufactured: 11/11/2021
• 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 Age: 30 YR
• Patient Sex: Male
• Patient Weight: 113 KG