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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 Problem Overheating of Device (1437)
Patient Problem Burning Sensation (2146)
Event Date 01/11/2022
Event Type  Injury  
Event Description
Information was received from a manufacturer representative (rep) regarding a patient (pt) who was implanted with an implantable neu rostimulator (ins). It was reported that the patient was feeling heating and burning sensation at pocket site while charging ins. Pt reports it feels like internal heating with lead wire where it connects into ins. Pt is very thin (100 lbs) and petite per caller. Pt says this heating became intense over past week and pt's husband says this has been going on for about 4 months. The agent reviewed checking to see if there have been any ins position changes at pocket site or changes in recharge practice that may be a factor. The agent also reviewed issue with recharger heating at base of paddle and to rule that out as an issue. Additional information was received from a manufacturer representative (rep) regarding a patient (pt) who was implanted with an implantable neurostimulator (ins). The rep reported that they were going to meet the patient on (b)(6) 2022 at their appointment to evaluate the system. They will reach out to the manufacturer to the day of the appointment. This information was also confirmed with a physician/account. Additional information was received. It was reported that the rep met with the patient today (b)(6) 2022 and confirmed the recharger heats up when recharging. The rep also mentioned the controller heats up as well. Patient lost a lot of weight and the rep can see the wires. The impedance check was normal per rep. A replacement recharger was sent to the patient. Additional information was received. It was reported that the ins heating issue was not resolved when the patient received their replacement recharger (rtm). The rep stated patient received the replacement recharger and with replacement, indicated that it feels like the ins is getting very hot af ter 3-4 minutes of recharging. The rep will meet with the patient again to re-evaluate. This was confirmed with the physician/account. The rep stated they (and the healthcare provider (hcp)) saw the patient last week and impedances were good. Caller confirmed that the issue is only when recharging. The agent suggested recharging best practices (using belt, using thin piece of clothing, etc. ), imaging to ensure the ins hasn't moved and potentially, moving ins to different location or replacing ins with a non-rechargeable.
 
Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.
 
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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
glen belmer
7000 central avenue ne rcw215
minneapolis, MN 55432
6122713209
MDR Report Key14602258
MDR Text Key293362139
Report Number3004209178-2022-07201
Device Sequence Number1
Product Code LGW
UDI-Device Identifier00643169781702
UDI-Public00643169781702
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,Company Representative
Reporter Occupation Non-Healthcare Professional
Type of Report Initial,Followup,Followup
Report Date 08/05/2022
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received06/06/2022
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date11/28/2019
Device Model Number97715
Device Catalogue Number97715
Was Device Available for Evaluation? No
Date Manufacturer Received08/01/2022
Was Device Evaluated by Manufacturer? No Answer Provided
Date Device Manufactured12/10/2018
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: 06/06/2022 Patient Sequence Number: 1
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