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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); Therapy Delivered to Incorrect Body Area (1508); Device Operates Differently Than Expected (2913)
Patient Problems Undesired Nerve Stimulation (1980); Pain (1994); Therapeutic Effects, Unexpected (2099); Tingling (2171); Therapeutic Response, Decreased (2271)
Event Date 06/21/2018
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 manufacturing representative (rep) regarding a patient implanted for spinal pain.The patient reported that their stimulation is constantly changing.They stated that their coverage will be good, and they will be getting some good relief, but then it will change.The patient noted that they woke up the other day, and stimulation was no longer helping.They stated that their overall relief is 20-25%.It was mentioned that the patient has been reprogrammed.The rep indicated that the patient will report tingling in areas of pain, and within a few weeks they will request another adjustment.It was stated that he patient has been met multiple times for reprogramming.The rep offered the patient high-density stimulation, but the patient stated they do not care much for it.The rep reprogrammed and gave the patient new groups to try.The issue was not resolved at the time od the report.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 manufacturing representative (rep) indicated that they met with the patient and the patient reported having stimulation on the left side in their ribs or legs, with no or very little stimulation in their back.The patient has been reprogrammed many times.It was noted that the physician was made aware of the efforts to reprogram.No further complications were reported or anticipated.
 
Manufacturer Narrative
Due to imdrf harmonization, any previously submitted device, method, result, and conclusion codes no longer apply to this event.If information is provided in the future, a supplemental report will be issued.
 
Event Description
Additional information received from the manufacturing representative (rep) indicated that the patient¿s stimulation seems to be normal fluctuation with positional movement.The rep stated that they reprogrammed the patient, and the patient reported great coverage at the end of the programming session.They noted that the patient continues to report 20-25% overall pain relief.The rep stated that the patient does have adaptive stimulation activated, thus their stimulation changes with positional movement.No further complications were reported or anticipated.
 
Manufacturer Narrative
Due to imdrf harmonization, any previously submitted device, method, result, and conclusion codes no longer apply to this event.If information is provided in the future, a supplemental report will be issued.
 
Event Description
Additional information received from the manufacturing representative (rep) indicated that the patient¿s stimulation seems to be normal fluctuation with positional movement.The rep stated that they reprogrammed the patient, and the patient reported great coverage at the end of the programming session.They noted that the patient continues to report 20-25% overall pain relief.The rep stated that the patient does have adaptive stimulation activated, thus their stimulation changes with positional movement.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
MDR Report Key7635304
MDR Text Key112708865
Report Number3004209178-2018-14266
Device Sequence Number1
Product Code LGW
UDI-Device Identifier00643169781702
UDI-Public00643169781702
Combination Product (y/n)N
PMA/PMN Number
P840001
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,consum
Type of Report Initial,Followup,Followup,Followup
Report Date 03/23/2020
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 Date02/14/2019
Device Model Number97715
Device Catalogue Number97715
Was Device Available for Evaluation? No
Initial Date Manufacturer Received 06/21/2018
Initial Date FDA Received06/25/2018
Supplement Dates Manufacturer Received06/29/2018
08/08/2018
02/28/2020
Supplement Dates FDA Received07/10/2018
10/05/2018
03/23/2020
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Patient Age51 YR
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