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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 Adverse Event Without Identified Device or Use Problem (2993)
Patient Problems Abdominal Pain (1685); Nerve Damage (1979); Pain (1994); Urinary Retention (2119); Urinary Frequency (2275); Sleep Dysfunction (2517)
Event Date 08/06/2019
Event Type  Injury  
Manufacturer Narrative

If information is provided in the future, a supplemental report will be issued.

 
Event Description

Information was received from a patient who was implanted with an implantable neurostimulator (ins) for non-malignant pain. Information was received from a patient (pt) regarding an implantable neurostimulator (ins). The reason for call was pt reported that since their device was implanted they've had issues with their bladder and pain that is worsening in their pelvic area. Pt stated they are unable to urinate when stimulation is turned on and they feel they need reprogramming. Pt went on to explain that they're unable to sleep because they have to urinate once an hour throughout the night. Pt mentioned their prior device was replaced due to normal battery depletion. Pt also mentioned their last implant had two groups and now this device has three groups. Pt explained that when they were having their device replaced with intellis, they didn't have the correct parts so they actually had to do the surgery twice "because no one knows what's in them". Pt also mentioned their doctor told them they think they have blunt force trauma to their nerves. Pt stated they are already working with their doctor in regards to the above noted issues and have an upcoming doctor appointment on (b)(6) 2021. The patient reported to a manufacturer representative that he was having pain and wanted to meet with a manufacturer representative at his next physician's appointment.

 
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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 Key12293671
MDR Text Key265578961
Report Number3004209178-2021-12072
Device Sequence Number1
Product Code LGW
Combination Product (Y/N)N
Reporter Country CodeUS
PMA/PMN NumberP840001
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type COMPANY REPRESENTATIVE,CONSUM
Reporter Occupation
Type of Report Initial
Report Date 08/09/2021
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received08/09/2021
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? No
Device Operator HEALTH PROFESSIONAL
Device EXPIRATION Date05/14/2020
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 Received07/20/2021
Was Device Evaluated By Manufacturer? No Answer Provided
Date Device Manufactured05/23/2019
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: 08/09/2021 Patient Sequence Number: 1
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