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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 Display or Visual Feedback Problem (1184); Migration or Expulsion of Device (1395); Energy Output Problem (1431); Insufficient Information (3190)
Patient Problems Insufficient Information (4580); No Clinical Signs, Symptoms or Conditions (4582)
Event Type  Injury  
Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.
 
Event Description
It was reported that the patient experienced ¿recurrent problems with her adaptivestim (as)¿ device. It was noted the issues started following a lead replacement procedure on (b)(6) 2021, during which the implantable neurostimulator (ins) was stated to have ¿become disoriented when removed and replaced in to the pocket. ¿ the ins was reported to have ¿misinterpreted the orientation as well as turned the stimulation to 0. 0 or up too high very randomly. ¿ the patient¿s settings were reset and the device reoriented from scratch multiple times, but the issue remained unresolved. It was further noted that the ins was reprogrammed completely or just reoriented and that the as transition time was reduced to 30 seconds. The ins pocket was expected to be snug and stable in the reporting manufacturer representative¿s (rep) opinion, as the pocket was was not revised and an absorbable antibacterial envelope was added during the revision procedure. The patient was booked for further review the week of (b)(6) 2021. The rep planned to make sure none of the patient¿s programmed values were set to 0. 0 ma and to increase the as transition time from 30 seconds during the meeting. The patient was instructed to check that their orientation was correct each time and the rep planned to check this again during their planned meeting. There were no further complications reported or anticipated.
 
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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 Key12500132
MDR Text Key272909675
Report Number3004209178-2021-14128
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,foreig
Reporter Occupation
Type of Report Initial,Followup,Followup
Report Date 09/23/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received09/20/2021
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date02/28/2021
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 Received09/22/2021
Was Device Evaluated by Manufacturer? No Answer Provided
Date Device Manufactured03/02/2020
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

Patient Treatment Data
Date Received: 09/20/2021 Patient Sequence Number: 1
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