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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 Device Operates Differently Than Expected (2913)
Patient Problem Pain (1994)
Event Date 12/27/2017
Event Type  Injury  
Manufacturer Narrative

Other applicable components are: product id 977a260, serial# (b)(4), implanted: (b)(6) 2017, product type: lead, product id: 977a260, serial# (b)(4), implanted: (b)(6) 2017, product type: lead. If information is provided in the future, a supplemental report will be issued.

 
Event Description

Information was received from a manufacturer's representative regarding a patient who was implanted with an implantable neurostimulator (ins). It was reported that an explant was planned for the patient's entire system. The patient described a new pain pattern they think is related to the leads. The patient saw their physician last week and had injections performed and discussed the explant. Additional information received. It was reported that the patient thought that the leads were irritating a nerve and causing the new pain pattern they were experiencing. No further complications reported.

 
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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 Key7155574
MDR Text Key96072644
Report Number3004209178-2017-26788
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 COMPANY REPRESENTATIVE,CONSUM
Reporter Occupation
Type of Report Initial
Report Date 12/29/2017
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received12/29/2017
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? Yes
Device Operator HEALTH PROFESSIONAL
Device EXPIRATION Date10/14/2018
Device MODEL Number97715
Device Catalogue Number97715
Was Device Available For Evaluation? No
Is The Reporter A Health Professional? No
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received12/27/2017
Was Device Evaluated By Manufacturer? No Answer Provided
Date Device Manufactured10/24/2017
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: 12/29/2017 Patient Sequence Number: 1
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