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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 Battery Problem (2885); Charging Problem (2892)
Patient Problem Pain (1994)
Event Date 08/11/2021
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 who was implanted with an implantable neurostimulator (ins) for spinal pain. It was reported that the patient stated their ins battery is not charging like it should. The patient stated she has had it plugged in for 1. 5 hours today but it is not "moving. " the patient clarified she has the recharger telemetry module (rtm) plugged into the controller but the ins battery level is not moving. While patient services (pss) was on the phone with the patient, she stated she saw the battery level go to 40% and it started at 0%. The patient verified she has excellent charge quality. Pss reviewed it could take up to 2. 5 hours to charge the ins battery complete from empty. The patient is going to charge the ins complete. The patient stated the last time she charged the ins, the battery only lasted a day, if that. The patient stated her ins battery charge usually lasts about 2-3 days. The patient stated she noticed the change in charge frequency 2 weeks ago. The patient verified she has not had any programming changes. The patient stated she just maybe increases slightly between 4. 0 and 5. 0. The patient reported she fell about 1 week ago. The patient stated her back has been hurting more for the past 3 days. The patient has been taking pain pills to help even with stim on. Pss suggested that the patient have her ins / leads checked and report the fall. 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
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 Key12395010
MDR Text Key271271021
Report Number3004209178-2021-13167
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
Report Date 08/31/2021
1 Device Was Involved in the Event
0 PatientS WERE Involved in the Event:
Date FDA Received08/31/2021
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? Yes
Device Operator HEALTH PROFESSIONAL
Device EXPIRATION Date03/28/2020
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 Received08/25/2021
Was Device Evaluated By Manufacturer? No Answer Provided
Date Device Manufactured04/05/2019
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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