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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); Adverse Event Without Identified Device or Use Problem (2993); Patient Device Interaction Problem (4001)
Patient Problems Fatigue (1849); Pain (1994); Sleep Dysfunction (2517); Ambulation Difficulties (2544); Insufficient Information (4580)
Event Date 10/03/2020
Event Type  malfunction  
Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.
 
Event Description
The patient (pt) reported that in the last couple of days, they have felt "wonky". Pt explained that they have had no energy, lots of pain, sleep was off, and stability was off. The patient noted that they are able to recharge the implantable neurostimulator and that they typically recharge when the implantable neurostimulator reaches 30% charge or lower. They usually recharge on saturday or sunday, and that when they are more active, they need their ins.  the patient unlocked the controller at the time of the report, and the pt confirmed the stimulation was off.  it was reviewed with the patient how to turn the ins back on, and the pt confirmed that they were successful with turning the therapy on (pt noted they felt stimulation again). Pt reported that this is not the first time that they have noticed the ins turning off. Pt reported that in at least the last 6-7 months, they have noticed this issue, and they had to see the hcp (health care professional)  to "get the funkyness out. " pt stated that they noticed this issue after physical therapy. Patient services reviewed controller capabilities, importance of keeping the ins charged, tracking the issue in a diary, and to follow-up with the health care professional.
 
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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
david gustafson
7000 central avenue ne rcw215
minneapolis, MN 55432
7635149628
MDR Report Key11771638
MDR Text Key251468354
Report Number3004209178-2021-07168
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 05/04/2021
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received05/04/2021
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date10/28/2019
Device Model Number97715
Device Catalogue Number97715
Was Device Available for Evaluation? No
Is the Reporter a Health Professional?
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received05/03/2021
Was Device Evaluated by Manufacturer? No Answer Provided
Date Device Manufactured10/30/2018
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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