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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 Failure to Deliver Energy (1211); Failure to Interrogate (1332); Overheating of Device (1437); Battery Problem (2885); Charging Problem (2892); Communication or Transmission Problem (2896); Connection Problem (2900)
Patient Problems Burn(s) (1757); Burning Sensation (2146); Discomfort (2330); Sleep Dysfunction (2517); Electric Shock (2554); No Clinical Signs, Symptoms or Conditions (4582)
Event Date 05/06/2021
Event Type  malfunction  
Manufacturer Narrative
Concomitant medical products: product id: 97755, serial# (b)(4), product type: recharger. Other relevant device(s) are: product id: 97755, serial/lot #: (b)(4),udi#:(b)(4). If information is provided in the future, a supplemental report will be issued.
 
Event Description
Information was received from a consumer regarding an internal neurostimulator (ins). It was reported via a patient representative that they were having difficulty charging the stimulator with the equipment for almost 3 months. The caller stated they were able to bend/curl the recharger to get things to charge but now they cannot connect and charge the stimulator at all. The caller confirmed the controller is fine but reported the recharger cord was frayed by the paddle. The caller stated the recharger began heating up and the patient felt the recharger burning, shocking, stinging them and a red burn mark was left on the patient's skin. They stated last night the patient couldn't sleep because the stimulation is off due to the depleted stimulator and being unable to charge. The caller stated the therapy works really well for the patient's symptoms. Troubleshooting was unable to be performed as troubleshooting was conducted with reps prior to calling patient services. Caller did not have the equipment with them and was not with the patient at the time of the call. They called back on registered phone number reiterating last night when they were recharging their implant they got a shock burn, the cord burned the patient. Patient reset the controller and attempted to charge their implant, patient was no longer able to charge their implant and the implant battery completely depleted. Patient mentioned they could charge with the ac power supply but not with the rtm. They sent an email to repair for an rtm replacement. During call the patient mentioned they had chronic pain.
 
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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 Key12426159
MDR Text Key272767068
Report Number3004209178-2021-13374
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
Report Date 09/04/2021
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received09/04/2021
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date07/28/2020
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 Received08/06/2021
Was Device Evaluated by Manufacturer? No Answer Provided
Date Device Manufactured08/06/2019
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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