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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 Problems Unintended Collision (1429); Energy Output Problem (1431); Inappropriate/Inadequate Shock/Stimulation (1574)
Patient Problems Device Overstimulation of Tissue (1991); Pain (1994); Discomfort (2330); Electric Shock (2554); Cramp(s) /Muscle Spasm(s) (4521)
Event Date 02/01/2021
Event Type  malfunction  
Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.
 
Event Description
It was reported that patient (pt) was in pain because of a broken hip due to a fall since 5 months ago(pt clarified fall was last february). Pt saw hcp, and hcp performed x-rays, but did not find any damage to hip. Then, on the third visit to the hcp, pt was referred to orthopedic hcp, who performed x-rays on front side of body and noticed bones broke in the hip area. Pt said the implant site was right above the pt's hip and the implant site was sore due to the broken hip since the fall. Pt did not want to take pain medication. The patient was redirected to their healthcare provider to further address the issue. Pt mentioned they have had several operations over the last two years and have an upcoming hip surgery. Patient mentioned they get an electric shock if they lay too hard on ins or lay/move the wrong way since about 6 months ago. It was reported they had raised their intensity settings to a 3 when they first tried different settings after implant date, but the intensity of a 3 was too high for the pt and caused discomfort. Pt said the higher intensity settings cause pain possibly due to injured hip. Pt also said the higher settings gave the pt "stomach spasms. " pt said they kept the settings low as to "not cause pain. " pt had informed a mdt rep. (name, unknown) sometime after implant date about the discomfort and "pain" caused by the high settings and mdt rep. Informed the pt the ins was "lying sideways," but pt's hcp explained to the pt that the pt's weight loss could be contributing to the discomfort and the movement of the ins. Pt said their nerves were "shot. " the patient was redirected to their healthcare provider to further address the issue. Pt mentioned they have had several operations over the last two years and have an upcoming hip surgery.
 
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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 Key12535344
MDR Text Key273580980
Report Number3004209178-2021-14447
Device Sequence Number1
Product Code LGW
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
P840001
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type consumer
Reporter Occupation
Type of Report Initial
Report Date 09/27/2021
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received09/27/2021
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date06/28/2020
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 Received09/20/2021
Was Device Evaluated by Manufacturer? No Answer Provided
Date Device Manufactured07/08/2019
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

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