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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 Intermittent Continuity (1121); Failure to Deliver Energy (1211); Inappropriate/Inadequate Shock/Stimulation (1574); Patient Device Interaction Problem (4001)
Patient Problems Erythema (1840); Inflammation (1932); Pain (1994); Therapeutic Effects, Unexpected (2099); Burning Sensation (2146); Electric Shock (2554)
Event Date 01/01/2020
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 non-malignant pain. The rep reported that the patient felt a shocking/jolting sensation at their implantable neurostimulator (ins) when they were getting out of bed the sunday morning prior to the report. It was noted that the patient did not fall or have any trauma. The rep stated that associated with the shock, the patient felt their complex regional pain syndrome flare up, and their entire left leg down to their foot got red and inflamed, which burned and was painful. In addition, the patient reported that their therapy is turning off by itself. The rep added that the issue subsided over two days. The rep checked impedances and indicated that they were normal. They added that when referencing contact 14, impedances were between 600-840 ohms. It was stated that the physician will be assessing the patient. The rep mentioned that since the jolt, the therapy has been working fine. 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 was received from a health care professional regarding the patient. It was reported that there was no change in the patient¿s weight at the time of the event. The cause of the therapy turning off by itself and the shocking was not determined. The health care professional did not think that the implantable neurostimulator was turning off by itself to his understanding. There were no further complications 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 Key9597456
MDR Text Key176617153
Report Number3004209178-2020-01237
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,health
Reporter Occupation
Type of Report Initial,Followup
Report Date 04/01/2020
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received01/16/2020
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date11/14/2019
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 Received03/17/2020
Was Device Evaluated by Manufacturer? No Answer Provided
Date Device Manufactured11/17/2018
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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