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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); Delayed Charge Time (2586); Charging Problem (2892); Communication or Transmission Problem (2896); Patient Device Interaction Problem (4001)
Patient Problem Device Overstimulation of Tissue (1991)
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 patient (pt) who was implanted with an implantable neurostimulator (ins) for spinal pain. It was reported that it had been taking a long time for them to recharge their ins. Pt said they have to charge their ins 3 times a day, during the day will have stimulation at 5 and at night turns it down to 3 (pt said when it is at 5 they don't feel the throbbing or the impulse, pt used to have stim at 6). Pt said when they turn it down to 3 it will drain 20% of their battery. Pt said when they look at the batteries while recharging, the controller battery will go from 100-90% while the ins battery will go from 60-70%. Pt said they don't want to sit for 2 hours a day to recharge and if they move a little bit, their recharge quality will go from excellent to good.   pt said they are going to look into having a new device put in. Patient services (pss) reviewed that the different intensity settings may affect how much the battery drains during the day and redirected back pt to the rep to pull recharging diagnostics on the ins. The patient was redirected to their healthcare provider to further address the issue.
 
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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 Key11664520
MDR Text Key267437438
Report Number3004209178-2021-05987
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 04/14/2021
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received04/14/2021
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date03/14/2021
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 Received04/09/2021
Was Device Evaluated by Manufacturer? No Answer Provided
Date Device Manufactured03/24/2020
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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