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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 Device Operates Differently Than Expected (2913)
Patient Problems Fainting (1847); High Blood Pressure/ Hypertension (1908); Pain (1994); Dizziness (2194); Therapeutic Response, Decreased (2271); Discomfort (2330); Complaint, Ill-Defined (2331)
Event Date 02/19/2018
Event Type  malfunction  
Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.
 
Event Description
Information was received from a consumer regarding a patient with an implantable neurostimulator (ins) for non-malignant pain. It was reported that the patient said the ins was working great but now the patient's pain had returned. The patient said she met with the manufacturer representative (rep) for a routine adjustment the week prior to the report and after the adjustment the patient was feeling great; the patient said now they can't seem to get the stimulation right to provide relief and the patient said they usually had the stimulation running low. The patient increased on both groups a and b and said that group a and b are for the right and left side. The patient stated that the right side was at 3. 7 and the left side was at 3. 5 but before the rep made an adjustment the patient was at 6. 0. The patient said that if they increased to 6. 0 now their "heart feels like it's going to jump out of my chest"; the patient said from increasing stimulation they got light headed like they were ready to faint, their blood pressure was a little high and they were uncomfortable/had uncomfortable stimulation. The patient reported that after the attempted adjustments they were still not getting relief in the right side but the left side was not painful. The patient said they still had stitches and inquired if taking a shower would affect the ins. The patient said most of the pain was in their "lower right back", glute area, down the side and outside of the calf. The patient was directed to their healthcare professional and it was reviewed that patient may need another adjustment. No further complications were reported/anticipated.
 
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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 Key7296689
MDR Text Key101243179
Report Number3004209178-2018-03958
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 02/26/2018
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received02/26/2018
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date01/14/2019
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 Received02/21/2018
Was Device Evaluated by Manufacturer? No Answer Provided
Date Device Manufactured01/21/2018
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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