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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 Problems Energy Output Problem (1431); Overheating of Device (1437); Therapy Delivered to Incorrect Body Area (1508); Data Problem (3196)
Patient Problems Abdominal Pain (1685); Undesired Nerve Stimulation (1980); Device Overstimulation of Tissue (1991); Pain (1994); Burning Sensation (2146); Complaint, Ill-Defined (2331)
Event Date 02/23/2020
Event Type  malfunction  
Manufacturer Narrative
Concomitant medical products: product id: 97755, serial#: (b)(4), product type: recharger, product id: 97745, serial#: (b)(4), product type: programmer, patient.If information is provided in the future, a supplemental report will be issued.
 
Event Description
Information was received from the consumer regarding a patient with an implantable neurostimulator (ins) for non-malignant pain.It was reported that the patient had been getting rm04 when they charged the ins and they would reset the controller to bypass the message.One day they reset the controller 5 times.They then reported that the area around the ins was hot.When trying to clarify if the hotness was external or internal the patient stated "yes".They reported that they were getting rm04 all the time, the recharger was overheating, and the controller had bent connector pins.The patient felt that their stimulation increased drastically and they had pain in the stomach area.They were advised to reduce stimulation and they should shut stimulation off if they couldn¿t.They mentioned they had a problem with the implant that was a temporary fix.They further reported that their stimulation increased suddenly without the patient making stimulation changes.Once stimulation increased from 10 to 29.95.They felt it through their stomach and they had been hurting because of it.When it happened their stomach blew up like a basketball.The patient stated they wouldn't choose to have their settings so high.No further complications were reported or anticipated.
 
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Brand Name
INTELLIS
Type of Device
STIMULATOR, 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 Key9836371
MDR Text Key183561734
Report Number3004209178-2020-05466
Device Sequence Number1
Product Code LGW
UDI-Device Identifier00643169781702
UDI-Public00643169781702
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 Non-Healthcare Professional
Type of Report Initial
Report Date 03/16/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Expiration Date03/14/2020
Device Model Number97715
Device Catalogue Number97715
Was Device Available for Evaluation? No
Initial Date Manufacturer Received 03/06/2020
Initial Date FDA Received03/16/2020
Date Device Manufactured03/27/2019
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial
Patient Sequence Number1
Patient Age66 YR
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