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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 Dehydration (1807); Hyperglycemia (1905); Pain (1994); Complaint, Ill-Defined (2331); Malaise (2359); Diabetic Ketoacidosis (2364); Reaction (2414)
Event Date 11/09/2017
Event Type  Injury  
Manufacturer Narrative
Review of this mdr and/or additional information received shows that there is no information to reasonably suggest that the device in this report may have caused or contributed to a death or serious injury. If information is provided in the future, a supplemental report will be issued.
 
Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.
 
Event Description
Information was received from a health care provider (hcp) and consumer regarding a patient who was implanted with a neurostimulator for spinal pain. It was noted that the patient¿s medical history includes diabetes. A diabetic insulin pump was noted to be in use and had been used prior to scs implant. It was reported that the patient was still in the hospital after implant. The implant occurred on (b)(6) 2017. ¿something happened¿ and the patient got really sick. The patient went into diabetic ketoacidosis and became dehydrated. It was confirmed that prior to the ins implant, the patient had diabetes and an implanted insulin pump. It was requested that a manufacturer representative program the patient¿s implantable neurostimulator (ins). The patient could not find that card that they were given by the manufacturer representative. Additional information was received from the hcp on (b)(6) 2017 reporting that the implant was not the cause of the patient¿s admission to the hospital. The patient was a brittle diabetic and had a reaction to steroids given in the emergency room for their pain. The steroids started the patient¿s problem with an increase of blood sugar. The implant was reported to be stable and was not the source. It again was clarified that the cause of the issue was the patient¿s pain control and not the stimulator. Actions taken that resolved the diabetic ketoacidosis, dehydration, and sickness were admission to medicine service, insulin, and dietary restriction. Patient weight was provided. No further complications were reported.
 
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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 00777
Manufacturer (Section G)
MEDTRONIC PUERTO RICO OPERATIONS CO.
road 31, km. 24, hm 4
ceiba norte industrial park
juncos PR 00777
Manufacturer Contact
lisa woodward clark
7000 central avenue ne rcw215
minneapolis, MN 55432
7635263920
MDR Report Key7118447
MDR Text Key103684299
Report Number3004209178-2017-26013
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,health professional
Reporter Occupation
Type of Report Initial,Followup
Report Date 12/22/2017
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received12/14/2017
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Expiration Date10/14/2018
Device Model Number97715
Device Catalogue Number97715
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? No
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received12/15/2017
Was Device Evaluated by Manufacturer? No Answer Provided
Date Device Manufactured10/17/2017
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: 12/14/2017 Patient Sequence Number: 1
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