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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 Battery Problem (2885)
Patient Problems High Blood Pressure/ Hypertension (1908); Nausea (1970); Dizziness (2194)
Event Date 01/09/2018
Event Type  malfunction  
Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.
 
Event Description
Additional information was received from a healthcare provider (hcp) via a manufacturer representative (rep). It was reported the patient first noticed their ins charge was depleting quickly on (b)(6) 2018. The cause of the higher blood pressure, nausea and dizzy spells remains unknown. The patient was going to meet with another doctor on (b)(6) 2018 regarding those symptoms. The pulse width has been adjusted to balance the charge burden and the pain relief. No further complications were reported or anticipated.
 
Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.
 
Event Description
Additional information received from the rep reported that the hcp met with the hcp on (b)(6) 2018 and (b)(6) 2018 and that the patient had the flu and was vomiting, but that these symptoms were not related to the device/therapy. The 'charge burden' had not been resolved since adjusting the pulse width. No further complications were reported.
 
Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.
 
Event Description
Information was received by a consumer regarding a patient who was implanted with a neurostimulator (ins) for non-malignant pain. It was reported that on (b)(6) 2018, the patient's pulse width (pw) was increased from 90 to 210, and then the following morning ((b)(6) 2018) they noticed their blood pressure was higher, they had nausea and dizzy spells. The pw was changed a second time on (b)(6) 2018 because the pw setting was draining their ins charge too quickly; it was lowered from 210 to 160, and again the following morning ((b)(6) 2018) they experienced the same symptoms. They were redirected to discuss with the patient's doctor. It was noted the patient had an appointment scheduled for (b)(6) 2018. No further complications were reported or 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 Key7241874
MDR Text Key103219743
Report Number3004209178-2018-02097
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 company representative,consum
Reporter Occupation
Type of Report Initial,Followup,Followup
Report Date 03/23/2018
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received02/05/2018
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date12/14/2018
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 Received03/05/2018
Was Device Evaluated by Manufacturer? No Answer Provided
Date Device Manufactured12/14/2017
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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