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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 Failure to Deliver Energy (1211); Battery Problem (2885)
Patient Problems Pain (1994); Sleep Dysfunction (2517); No Clinical Signs, Symptoms or Conditions (4582)
Event Date 02/27/2021
Event Type  malfunction  
Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.
 
Event Description
It was reported that patient (pt) started seeing a screen saying to recharge the implant and it said poor charge quality, and that both the implant and controller were at 100 percent. Patient services (pss) asked what the issue was and they said "it should have been down to 60 percent by that time". They said that on "saturday and sunday it sat at 100 percent and it should have gone down and talked to my rep on saturday and they asked if i have taken the battery out and put it back in and i said i tried that already". Pt said the implant "usually goes down 30-40 percent during the day and maybe 20-30 percent through the night. " pss had pt connect with the implant and it shows she is on group a and stimulation is on. Pt says implant is at 90 percent and controller is at 100 percent. Patient was told that somehow their stimulation got turned off, and that is probably why their ins battery level wasn't depleting over the weekend. Now that pt has confirmed their stimulation is on, pss suggested watching battery level to make sure its still depleting and to follow up with healthcare provider. It was reported that the patient had been sitting 1 1/2 hrs still on 70%. After 1 1/2 hr the battery went to 90%. Patient stated that if they move, connection drops when and even when they don't move. Patient stated no environmental factors. Patient stated they were doing as they have for years. Patient stated a guy said their unit was perfect, no problem. Patient stated issue not resolved and they want a new unit however they were not getting service. Patient reported issues and their back is keeping them up all night. Additional information was received. It was reported that the past two to three days, the patient's controller showed that their implantable neurostimulator (ins) battery was 100% and it didn't decrease. During this time the patient was "hurting". During the call, the patient verified that their stimulation was turned off so the patient turned their stimulation back on. The patient doesn't think they accidentally turned off their stimulation and they denied their ins battery getting so low that the stimulation turned off. The caller was redirected to their manufacturer representative.
 
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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 Key11739678
MDR Text Key265890883
Report Number3004209178-2021-06855
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 04/28/2021
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received04/28/2021
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date05/28/2020
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 Received04/27/2021
Was Device Evaluated by Manufacturer? No Answer Provided
Date Device Manufactured06/10/2019
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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