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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 Material Frayed (1262); Overheating of Device (1437); Delayed Charge Time (2586)
Patient Problems Burn(s) (1757); No Clinical Signs, Symptoms or Conditions (4582)
Event Date 10/26/2021
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). Date of event: date is approximate. If information is provided in the future, a supplemental report will be issued.
 
Event Description
Information was received from a manufacturer representative (rep) regarding a patient who was implanted with an implantable neurostimulator (ins). It was reported that the recharger is taking too long to charge ins, is heating up and has a frayed cord. Additional information was received from the patient. The patient wrote in that the battery is overheating causing the other components of the recharger to become so hot they burn the patient's skin. The recharging unit is becoming frayed. Recharging now takes up to 8-12 hours just for the unit in the patient's butt because they have to let the components cool down for it to keep charging. The patient has to sit in one position for that long before they can unplug and recharge the battery in the recharger itself. The manufacturer reached out to the patient to make sure they got the replacement recharger (rtm) that was sent. A woman answered the phone and was asked to have the patient call the manufacturer and the manufacturer provided the phone number.
 
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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 Key12953283
MDR Text Key286447857
Report Number3004209178-2021-18114
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 01/21/2022
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received12/07/2021
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date12/28/2018
Device Model Number97715
Device Catalogue Number97715
Was Device Available for Evaluation? No
Date Manufacturer Received01/13/2022
Was Device Evaluated by Manufacturer? No Answer Provided
Date Device Manufactured01/08/2018
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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