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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: MEDTRONIC PUERTO RICO OPERATIONS CO. INTELLIS STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF

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MEDTRONIC PUERTO RICO OPERATIONS CO. INTELLIS STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF Back to Search Results
Model Number 97715
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problems Purulent Discharge (1812); Edema (1820); Unspecified Infection (1930); Seroma (2069); Swelling (2091); Complaint, Ill-Defined (2331)
Event Date 09/03/2020
Event Type  Injury  
Manufacturer Narrative

Concomitant medical products: product id: 977a290, serial#: (b)(4), implanted: (b)(6) 2020, product type: lead. Product id: 977a290, serial#: (b)(4), implanted: (b)(6) 2020, product type: lead. Other relevant device(s) are: product id: 977a290, serial/lot #: (b)(4), ubd: 29-jan-2024, udi#: (b)(4). Product id: 977a290, serial/lot #: (b)(4), ubd: 29-jan-2024, udi#: (b)(4). If information is provided in the future, a supplemental report will be issued.

 
Event Description

The healthcare professional (hcp) reported through a manufacturer representative that after a follow-up mri, the patient was found to have experienced fluid collection with surrounding soft tissue edema along their lead wire. It was further reported the patient exhibited purulent discharge from the wound on the patient¿s back site. The physician decided to scrape out the infected area; the ¿swollen wound was scraped and a biopsy was requested. ¿ it was noted that the ¿patient was expected to be admitted to the hospital, administered antibiotics, and consulted with an infection medicine department. ¿ the leads remained implanted at the time of report; however, it was noted the issue was not resolved at that time. The hospital ¿requested a sterilization and numerical examination of the operating room and the results were found to be normal. ¿ there was ¿nothing special¿ reported regarding external factors that may have led or contributed to the issue. There were no further complications reported or anticipated.

 
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Brand NameINTELLIS
Type of DeviceSTIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF
Manufacturer (Section D)
MEDTRONIC PUERTO RICO OPERATIONS CO.
road 31, km. 24, hm 4
ceiba norte industrial park
juncos,pr MN 00777
Manufacturer (Section G)
MEDTRONIC PUERTO RICO OPERATIONS CO.
road 31, km. 24, hm 4
ceiba norte industrial park
juncos,pr MN 00777
Manufacturer Contact
david gustafson
7000 central avenue ne rcw215
minneapolis, MN 55432
7635149628
MDR Report Key10613548
MDR Text Key209401441
Report Number2182207-2020-00996
Device Sequence Number1
Product Code LGW
Combination Product (Y/N)N
Reporter Country CodeKS
PMA/PMN NumberP840001
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type COMPANY REPRESENTATIVE,FOREIG
Reporter Occupation
Type of Report Initial,Followup
Report Date 11/05/2020
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received10/01/2020
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? No
Device Operator HEALTH PROFESSIONAL
Device EXPIRATION Date02/28/2021
Device MODEL Number97715
Device Catalogue Number97715
Was Device Available For Evaluation? No
Is The Reporter A Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received10/17/2020
Was Device Evaluated By Manufacturer? No Answer Provided
Date Device Manufactured03/11/2020
Is The Device Single Use? Yes
Is this a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

Patient TREATMENT DATA
Date Received: 10/01/2020 Patient Sequence Number: 1
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