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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

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MEDTRONIC PUERTO RICO OPERATIONS CO. INTELLIS STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR Back to Search Results
Model Number 97715
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problems Erosion (1750); Foreign Body Reaction (1868); Hypersensitivity/Allergic reaction (1907); Pain (1994); Pocket Erosion (2013); Impaired Healing (2378); Sleep Dysfunction (2517); Fluid Discharge (2686); Alteration in Body Temperature (4568); Swelling/ Edema (4577)
Event Date 11/23/2020
Event Type  Injury  
Manufacturer Narrative

Concomitant medical products: product id; 977c265, lot#: none, serial# (b)(4), implanted: (b)(6) 2020, explanted: none. Product type: lead. Other relevant device(s) are: product id: 977c265, serial/lot #: (b)(4), ubd: 09-mar-2021, udi#: (b)(4). If information is provided in the future, a supplemental report will be issued.

 
Event Description

Information was received from a patient (pt) who was implanted with an implantable neurostimulator (ins). The patient reported that he has an opening in his back and he went to the er to have it checked. The patient stated that the er physician told him to have the ins taken out. Pt stated they tested the fluid coming out of the ins site and it is not infected, but pt stated he has swelling the size of a baseball at the ins site and it is causing him pain. Pt stated he has not had one good day with this ins since it was placed. The patient is requesting another neurosurgeon to take the ins out of their back. Pt said since day 1 they have had a serious issue. Pt said all of a sudden they got a baseball sized hole where the battery was and had an opening in their back from the wires that were put in. Pt said they went to see their pain doctor almost 3 weeks ago. Pt then saw family practice doctor on saturday and that doctor did not like the way the pt's issue looked. Pt said they didn't want to see their surgeon again. Pt said they had been walking around in severe pain. Additional information was received from a manufacturer representative and the patient. The patient was thought to have an infection prior, but a surgeon determined that he is allergic to the titanium in the implantable neurostimulator, and that the patient is having an allergic reaction. The battery pocket is hot to the touch and causing pain. It was noted that the opening wasn't closing. Due the pain, the patient had sleepless nights. The patient is scheduling for device explant, perhaps the week of (b)(6) 2021.

 
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Brand NameINTELLIS
Type of DeviceSTIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR
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
david gustafson
7000 central avenue ne rcw215
minneapolis, MN 55432
7635149628
MDR Report Key12170197
MDR Text Key261709757
Report Number3004209178-2021-10859
Device Sequence Number1
Product Code LGW
Combination Product (Y/N)N
Reporter Country CodeUS
PMA/PMN NumberP840001
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type COMPANY REPRESENTATIVE,CONSUM
Reporter Occupation
Type of Report Initial
Report Date 07/14/2021
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received07/14/2021
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? No
Device Operator HEALTH PROFESSIONAL
Device MODEL Number97715
Device Catalogue Number97715
Was Device Available For Evaluation? No
Is The Reporter A Health Professional?
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received07/13/2021
Was Device Evaluated By Manufacturer? No Answer Provided
Date Device Manufactured10/23/2020
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: 07/14/2021 Patient Sequence Number: 1
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