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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 97716
Device Problems Overheating of Device (1437); Battery Problem (2885); Charging Problem (2892)
Patient Problem Burn(s) (1757)
Event Date 03/03/2021
Event Type  Injury  
Manufacturer Narrative
Mfr site: (b)(4). If information is provided in the future, a supplemental report will be issued.
 
Event Description
Information was received from a distributor regarding a patient with an implantable neurostimulator (ins). It was reported that there was an ins problem. The patient controller had presented the heating message and had stopped recharging. The ins was hot and red. The next day the patient went to the clinic and observed the same heating problem, so the control reset procedure was done (in both ways). It was put to charge again and when it reached 60% of charge, the patient controller presented the message of completed and did not allow to charge any more. The distributor scheduled another date with the patient to test another patient controller and charger and asked the patient to inform them about the duration of the charge. A few hours later, the patient reported that the ins was discharged. On (b)(6) 2021 a test with another carrier was going to be done and before the technician arrived the patient sent a photo that the patient controller presents the message eri (elective replacement indicator). Recharge with another patient controller and antenna was done but had the same problem. The patient managed to charge until 100%, but at the end of the night the ins was ou t of battery. The patient controller displayed screen 50. The cause was unknown. The patient was hospitalized, and the ins will be replaced on (b)(6) 2021. The patient was alive with no injury.
 
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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 Key11529143
MDR Text Key241078507
Report Number3004209178-2021-04587
Device Sequence Number1
Product Code LGW
Combination Product (y/n)N
PMA/PMN Number
P840001
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type distributor,foreign
Reporter Occupation
Type of Report Initial,Followup
Report Date 04/23/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received03/19/2021
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date09/14/2021
Device Model Number97716
Device Catalogue Number97716
Was Device Available for Evaluation? No
Is the Reporter a Health Professional?
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received04/19/2021
Was Device Evaluated by Manufacturer? No Answer Provided
Date Device Manufactured09/14/2020
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: 03/19/2021 Patient Sequence Number: 1
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