MAUDE Adverse Event Report: MEDTRONIC PUERTO RICO OPERATIONS CO. INTELLIS; STIMULATOR, ELECTRICAL, IMPLANTED, FOR ESSENTI

Model Number 97715

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

Patient Problems Unspecified Infection (1930); Impaired Healing (2378); Fluid Discharge (2686)

Event Date 03/21/2022

Event Type  Injury  

Event Description

Information was received from a healthcare provider (hcp), via the manufacturer¿s representative (rep), who reported the patient had continuous wound drainage at the incision site that wouldn¿t heal with extensive antibiotics.The consumer had balance issues due to their disorder and would fall occasionally, but it didn¿t appear to be cause for the issue.It was unknown what led to the issue.The system was removed on (b)(6)2022 due to an infection after prolonged antibiotics to treat the drainage from one of the patient¿s scalp incisions that never healed as the hcp was worried about side effects from long term antibiotics.

Manufacturer Narrative

Other relevant device(s) are: product id 3387s-40 ,lot# v568684, implanted: (b)(6)2010,explanted: (b)(6) 2022,product type :lead; product id 3387s-40, lot# v591417 ,implanted: (b)(6)2011,explanted: (b)(6)2022,product type: lead ;product id 3389s-40 ,lot# va1n3xx , implanted: (b)(6) 2018, explanted: (b)(6) 2022,product type: lead ;product id 3389s-40, lot# va1r55f ,implanted: (b)(6) 2018,explanted: (b)(6) 2022,product type :lead; product id 3708260 serial# (b)(4), implanted: (b)(6) 2019,explanted: (b)(6) 2022,product type :extension ;product id 3708260 , serial#(b)(4), implanted: (b)(6) 2019,explanted:(b)(6) 2022 ,product type: extension; other relevant device(s) are: product id: 3387s-40, serial/lot #: (b)(4), ubd: 23-jul-2013, udi#: (b)(4) ; product id: 3387s-40, serial/lot #: (b)(4), ubd: 01-jul-2013, udi#: (b)(4) ; product id: 3389s-40, serial/lot #: (b)(4), ubd: 16-aug-2020, udi#: (b)(4) ; product id: 3389s-40, serial/lot #: (b)(4), ubd: 27-feb-2021, udi#: (b)(4) ; product id: 3708260, serial/lot #: (b)(4), ubd: 11-may-2022, udi#: (b)(4) ; product id: 3708260, serial/lot #: (b)(4), ubd: 11-jun-2022, udi#: (b)(4).If information is provided in the future, a supplemental report will be issued.

• Brand Name: INTELLIS
• Type of Device: STIMULATOR, ELECTRICAL, IMPLANTED, FOR ESSENTI
• Manufacturer (Section D): MEDTRONIC PUERTO RICO OPERATIONS CO.; road 31, km. 24, hm 4; ceiba norte industrial park; juncos PR 00777
• Manufacturer (Section G): MEDTRONIC PUERTO RICO OPERATIONS CO.; road 31, km. 24, hm 4; ceiba norte industrial park; juncos PR 00777
• Manufacturer Contact: glen belmer ; 7000 central avenue ne rcw215; minneapolis, MN 55432 ; 6122713209
• MDR Report Key: 13888279
• MDR Text Key: 287816898
• Report Number: 3004209178-2022-03695
• Device Sequence Number: 1
• Product Code: PJS
• UDI-Device Identifier: 00643169781702
• UDI-Public: 00643169781702
• 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: 03/24/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/24/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 08/28/2019
• Device Model Number: 97715
• Device Catalogue Number: 97715
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 03/21/2022
• Date Device Manufactured: 09/10/2018
• 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 Outcome(s): Required Intervention
• Patient Age: 64 YR
• Patient Sex: Male