MAUDE Adverse Event Report: MPRI SENSIGHT

Model Number	B3400060M
Medical Device Problem Code	Component Missing (2306)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/15/2021
Type of Reportable Event	Malfunction
Event or Problem 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.
Additional Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.
Event or Problem 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.
Additional 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
• Report Number: 2649622-2021-25108
• Device Sequence Number: 4452627
• Product Code: MHY
• UDI-Device Identifier: 00763000426484
• UDI-Public: 00763000426484
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• PMA/510(K) Number: P960009
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2021
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 01/05/2022

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
• Operator of Device: Health Professional
• Device Expiration Date: 11/11/2023
• Device Model Number: B3400060M
• Device Catalogue Number: B3400060M
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/15/2021
• Supplement Date Received by Manufacturer: 12/23/2021
• Initial Report FDA Received Date: 12/17/2021
• Supplement Report FDA Received Date: 01/05/2022
• Date Device Manufactured: 11/11/2021
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Age: 30 YR
• Patient Sex: Male
• Patient Weight: 113 KG