MAUDE Adverse Event Report: MPRI SENSIGHT; STIMULATOR, ELECTRICAL, IMPLANTED, FOR ESSENTI

Model Number B3301542M

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Bacterial Infection (1735)

Event Date 03/26/2022

Event Type  Injury  

Manufacturer Narrative

Concomitant medical products: product id: b32000, lot#: 082m27121, implanted: (b)(6) 2022, explanted: (b)(6) 2022, product type: accessory; product id: b31000, lot# 082t30721, implanted: (b)(6) 2022, explanted: (b)(6) 2022, product type: accessory; product id: b3301542, serial#: (b)(4), implanted: (b)(6) 2022, explanted: (b)(6) 2022, product type: lead; product id: b32000, lot# 082m27121, implanted: (b)(6) 2022, explanted: (b)(6) 2022, product type: accessory.Other relevant device(s) are: product id: b31000, serial/lot #: (b)(4), ubd: 03-nov-2023, udi#: (b)(4); product id: b32000, serial/lot #:(b)(4), ubd: 28-sep-2023, udi#: (b)(4).If information is provided in the future, a supplemental report will be issued.

Event Description

It was reported that post lead implant, infection set in (serratia marcescence +).Per the healthcare professional, the leads were explanted on (b)(6) 2022. the issue was resolved at this time.

• Brand Name: SENSIGHT
• Type of Device: STIMULATOR, ELECTRICAL, IMPLANTED, FOR ESSENTI
• 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: 14239044
• MDR Text Key: 290306987
• Report Number: 2649622-2022-08183
• Device Sequence Number: 1
• Product Code: PJS
• UDI-Device Identifier: 00763000426446
• UDI-Public: 00763000426446
• 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: Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 04/28/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/28/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 12/09/2023
• Device Model Number: B3301542M
• Device Catalogue Number: B3301542M
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 04/26/2022
• Date Device Manufactured: 12/09/2021
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 71 YR
• Patient Sex: Male
• Patient Weight: 117 KG