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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 Overheating of Device (1437); Battery Problem (2885); Communication or Transmission Problem (2896); Insufficient Information (3190)
Patient Problems Arthritis (1723); Burn(s) (1757); Erythema (1840)
Event Date 01/27/2021
Event Type  malfunction  
Manufacturer Narrative
Concomitant medical products: product id: 97755, serial#: (b)(4), product type: recharger. 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). It was reported that¿about 6 weeks ago recharger had stopped working so they met with manufacturer representative (rep) and rep got it set and it started working, then recharger started working intermittently so patient had to have another appointment with rep because recharger was having issues. After the meeting, rep told them to call patient services (ps) for replacement (s). Patient reported the issue was that the recharger antenna would get very hot and burn them. Patient said that they weren't actually physically burnt but that the recharger antenna had left red marks on their skin. Patient said there was a crack in the recharger antenna. Patient said that rep had done "everything" regarding troubleshooting. Controller showed 'no device found' when patient tried connecting with implant, wirelessly, patient confirmed implant battery was completely depleted and they now realized how much the therapy helped with her legs and hips now that they didn't have it right now. Controller charged like normal from ac power supply. Patient said they weren't able to take battery pack out of controller b/c they had rheumatoid arthritis. Controller appeared to be functioning as expected. Reviewed that only rtm would be replaced (for now) (patient had said that rep told her to have equipment replaced and patient seemed to be under assumption that everything would be replaced).
 
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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 Key11463458
MDR Text Key239156178
Report Number3004209178-2021-04118
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,Followup
Report Date 06/28/2021
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received03/11/2021
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date02/14/2019
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 Received06/11/2021
Was Device Evaluated by Manufacturer? No Answer Provided
Date Device Manufactured02/27/2018
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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