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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 Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problems Sepsis (2067); Post Operative Wound Infection (2446)
Event Date 11/08/2018
Event Type  Injury  
Manufacturer Narrative
Concomitant medical products: product id: 977a260, serial# (b)(4), implanted: (b)(6) 2018, explanted: (b)(6) 2018, product type: lead; product id: 977a260, serial# (b)(4), implanted: (b)(6) 2018, explanted: (b)(6) 2018, product type: lead. If information is provided in the future, a supplemental report will be issued.
 
Event Description
Information was received by a manufacture representative (rep) regarding a patient with an implantable neurostimulator (ins) for non-malignant pain. It was reported that the patient had a post-operative infection. It was reported that they did not report symptoms to their provider until nearly septic. It was unknown what diagnostics/troubleshooting was performed, but the device was fully explanted and the issue was resolved at the time of the report. The devices were explanted on (b)(6) 2018 and would not be returned due to the customer discarding them. The event occurred on (b)(6) 2018. No further complications were reported/anticipated.
 
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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
lisa woodward clark
7000 central avenue ne rcw215
minneapolis, MN 55432
7635263920
MDR Report Key8061691
MDR Text Key126944471
Report Number3004209178-2018-25258
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 11/12/2018
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received11/12/2018
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Expiration Date07/14/2019
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 Received11/08/2018
Was Device Evaluated by Manufacturer? No Answer Provided
Date Device Manufactured07/20/2018
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: 11/12/2018 Patient Sequence Number: 1
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