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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 Energy Output Problem (1431); Overheating of Device (1437); Battery Problem (2885); Insufficient Information (3190)
Patient Problems Unspecified Infection (1930); Pain (1994); Burning Sensation (2146); Swelling/ Edema (4577)
Event Date 08/02/2020
Event Type  Injury  
Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.
 
Event Description
The manufacturer representative (rep) reported that they obtained the operative report for the explant of the spinal cord stimulation system on (b)(6) 2021.   reading from the report they reported the following: the implanted neurostimulator (ins) was malfunctioning however it also indicated the ins had reached end of life (eol/eos).   several weeks prior to the explant, the patient was examined and that for the last 6 months the ins had been getting warm, it was not holding a charge, and stimulation was not covering their areas of pain.    there was also the report of swelling at the ins site, so there was concern of an infection due to the patient having diabetes and multiple risk factors.   the patient had been explained the risks/alternatives and the patient chose to have the system completely removed on (b)(6) 2021.
 
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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 Key12460381
MDR Text Key271042867
Report Number3004209178-2021-13711
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 company representative
Reporter Occupation
Type of Report Initial
Report Date 09/13/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received09/13/2021
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date01/28/2020
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 Received09/03/2021
Was Device Evaluated by Manufacturer? No Answer Provided
Date Device Manufactured01/31/2019
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: 09/13/2021 Patient Sequence Number: 1
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