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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 Battery Problem (2885); Insufficient Information (3190)
Patient Problems Unspecified Infection (1930); Pain (1994); Rash (2033); Discomfort (2330); Insufficient Information (4580)
Event Date 09/15/2021
Event Type  Injury  
Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.
 
Event Description
Information was received from a patient who was implanted with an implantable neurostimulator (ins) for non-malignant pain. The reason for call was pt stated he has developed a "rash / hives" on his back and it has grown down his legs and buttocks - and today it is on his arms for about a week and getting worse. Pt did have an earache about a week ago and went to the pcp dr - hcp at that time thought the rash was "blood infection" separate from the ear infection. Antibiotics given and the earache has gone away but the rash is still there. Pt reported pain on his front side near stomach and back area near the ins site today (b)(6) 2021. Pt stated he read on "the internet" that his symptoms could be related the ins.   pt asked if his symptoms could be caused by the ins battery. Pt verified that the ins site does not feel swollen or warm to the touch. Pt stated he used to be able to feel the ins battery pack and see the outline of the ins but he can't see that ins outline anymore. Pt stated he noticed today that the ins battery is discharging faster than it has in the past. No traumas / falls reported. Pss suggested pt contact his hcp to have the ins checked and discuss his symptoms. Pt stated he has a follow up appt with his pcp hcp. Pss suggested that pt consult with the implant hcp - pt stated he has to go through workmans comp to scheduled that appt. The patient was redirected to their healthcare provider to further address the issue.
 
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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 Key12543528
MDR Text Key273677638
Report Number3004209178-2021-14533
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 09/28/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received09/28/2021
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date11/14/2019
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 Received09/22/2021
Was Device Evaluated by Manufacturer? No Answer Provided
Date Device Manufactured11/17/2018
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: 09/28/2021 Patient Sequence Number: 1
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