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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); Unintended Collision (1429); Energy Output Problem (1431)
Patient Problem Device Overstimulation of Tissue (1991)
Event Date 10/22/2021
Event Type  malfunction  
Event Description
Information was received from a patient who was implanted with an implantable neurostimulator (ins) for spinal pain, cervical/neck, and failed back surgery syndrome. It was reported that the patient was in a car accident on october 22, and after the accident the ins started overstimulating the patient. They shut the ins down and went to the er to make sure everything with the system was in place and they said that it was. They then went on steroids to see if the swelling would go down and see if that would help the ins work. The patient talked to a representative and doctors immediately after the accident and they wondered if the swelling was causing the issue. The stimulation was supposed to go up to their c3 in their neck, but they now only felt stimulation up in their t1 maybe. The patient was getting injections from their healthcare provider on wednesday and they asked if a representative was available to meet for reprogramming as their normal representative was out of town. The patient was redirected to their healthcare provider to further address the issue.
 
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 Key12778129
MDR Text Key282587683
Report Number3004209178-2021-16661
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
Reporter Occupation Non-Healthcare Professional
Type of Report Initial
Report Date 11/09/2021
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received11/09/2021
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 Received10/22/2021
Was Device Evaluated by Manufacturer? No Answer Provided
Date Device Manufactured11/28/2018
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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