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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 Intermittent Continuity (1121); Failure to Deliver Energy (1211); Malposition of Device (2616)
Patient Problems Pain (1994); Therapeutic Effects, Unexpected (2099); Complaint, Ill-Defined (2331); Sleep Dysfunction (2517)
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 unknown indications for use. ·         it was reported that the patient's ins that was implanted in (b)(6) 2019 was causing the patient so much pain because of where it was placed. They stated that they could not sleep, lay back or sit. They reported it was misery. The patient was diagnosed with reflex sympathetic dystrophy (rsd). On top of that they stated that stimulation would just shut itself off and the patient would recharge and would never let it go below 60 percent. The patient stated that they would check their device and it would randomly be shut off. The patient stated that their stimulator device and leads were taken out last month due to the combination of these things.
 
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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 Key10752267
MDR Text Key214805966
Report Number3004209178-2020-18876
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
Report Date 10/28/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received10/28/2020
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date05/28/2020
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 Received10/27/2020
Was Device Evaluated by Manufacturer? No Answer Provided
Date Device Manufactured06/06/2019
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: 10/28/2020 Patient Sequence Number: 1
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