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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 PAIN RELIEF

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MEDTRONIC PUERTO RICO OPERATIONS CO. INTELLIS STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF Back to Search Results
Model Number 97715
Device Problems Unintended Collision (1429); Charging Problem (2892)
Patient Problems Pain (1994); Sleep Dysfunction (2517)
Event Date 12/31/2020
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 non-malignant pain. Information was received from a patient (pt) regarding an implantable neurostimulator (ins). Patient (pt) reported pain, and a fall. The patient was redirected to their healthcare provider to further address the issue. Pt said they have been "really hurting, it had been ramping up and i was having trouble sleeping". Pt says this issue started thursday and says it is because they can't charge their implant, and can't feel stimulation. Pt mentioned they took a "really bad fall on (b)(6)" but that was before this pain started and controller issue started. Pt says that after this fall, they went to the er via ambulance, and had xrays done. Pt said they found that they had "several sprains in my foot and shoulder and hands and have bruises but didn't break anything". Pt reported that they will be following up with healthcare provider (hcp).
 
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Brand NameINTELLIS
Type of DeviceSTIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF
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 Key11132381
MDR Text Key225556924
Report Number3004209178-2021-00326
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,Followup
Report Date 03/01/2021
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received01/07/2021
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date08/28/2019
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 Received02/26/2021
Was Device Evaluated by Manufacturer? No Answer Provided
Date Device Manufactured09/04/2018
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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