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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 Energy Output Problem (1431)
Patient Problems Device Overstimulation of Tissue (1991); Pain (1994); Discomfort (2330); Insufficient Information (4580)
Event Date 04/19/2021
Event Type  Malfunction  
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 spinal pain. It was reported that since date of implant the patient had to turn their intensity up so high (between 11 and 13) and their left side hurt due to the high stimulation. The patient said it felt like they were punched in the ribs and they are always sore. Since their settings are so high the patient has to charge their ins very often which is frustrating for the patient. The patient is going to ask their health care provider to have their spinal cord stimulator removed. Patient services specialist documenting reported event. The patient mentioned unrelated medical history including the patient is missing a hand.

 
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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 Key12233380
MDR Text Key264154989
Report Number3004209178-2021-11488
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 CONSUMER
Reporter Occupation
Type of Report Initial
Report Date 07/27/2021
1 Device Was Involved in the Event
0 PatientS WERE Involved in the Event:
Date FDA Received07/27/2021
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? Yes
Device Operator HEALTH PROFESSIONAL
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 Received07/23/2021
Was Device Evaluated By Manufacturer? No Answer Provided
Date Device Manufactured03/05/2021
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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