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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

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MEDTRONIC PUERTO RICO OPERATIONS CO. INTELLIS STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR Back to Search Results
Model Number 97715
Device Problems Failure to Deliver Energy (1211); Delayed Charge Time (2586)
Patient Problem Sleep Dysfunction (2517)
Event Date 07/02/2021
Event Type  Malfunction  
Manufacturer Narrative

If information is provided in the future, a supplemental report will be issued.

 
Event Description

The patient reported that on (b)(6) 2021, they were woken up in the morning because they felt their stimulation shut off, however, when the patient checked their controller it showed the implanted neurostimulator (ins) was charged to 60% and it did not indicate the stimulation was off.  the patient then turned the stimulation back on, but 10 minutes later, they felt the loss of stimulation again.  they turned it back on again.  this continued for 45 minutes, and then they decided to charge the ins. Once the controller showed 100% on the screen, it took another hour to indicate charging was finished.   the patient confirmed that the loss of stimulation they were experiencing had occurred when they were laying down and when they were sitting up, and they did not have adaptivestim active.  the only thing the patient could recall that may have contributed to this event was a fall they had when getting out of the shower a few days prior to the report. The patient was redirected to see their doctor to have the ins checked.

 
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Brand NameINTELLIS
Type of DeviceSTIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR
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 Key12122009
MDR Text Key260299886
Report Number3004209178-2021-10414
Device Sequence Number1
Product Code LGW
Combination Product (Y/N)N
Reporter Country CodeUS
PMA/PMN NumberP840001
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type CONSUMER
Reporter Occupation
Type of Report Initial,Followup
Report Date 07/28/2021
1 Device Was Involved in the Event
0 PatientS WERE Involved in the Event:
Date FDA Received07/06/2021
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? Yes
Device Operator HEALTH PROFESSIONAL
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 Received07/26/2021
Was Device Evaluated By Manufacturer? No Answer Provided
Date Device Manufactured11/10/2020
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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