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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 High impedance (1291); Connection Problem (2900)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 07/10/2020
Event Type  Malfunction  
Manufacturer Narrative

Concomitant medical products: product id: 37714, serial#: (b)(4), implanted: (b)(6) 2012, explanted: (b)(6) 2020, product type: implantable neurostimulator. Product id: 39565-65, serial#: (b)(4), implanted: (b)(6) 2012, product type: lead. Product id: 39565-65, serial#: (b)(4), implanted: (b)(6) 2012, product type: lead. Other relevant device(s) are: product id: 39565-65, serial/lot #: (b)(4), ubd: 06-feb-2016, udi#: (b)(4). If information is provided in the future, a supplemental report will be issued.

 
Event Description

Information was received from a manufacturer representative regarding a patient who is implanted with a neurostimulator. It was reported that on (b)(6), during an ipg replacement, 8-15 lead was stuck in 37714. When finally removed from old ipg lead appeared intact, but would not advance into 97715. Additional information was received from a manufacturer representative regarding the patient on 2020-jul-21. The reason for the replacement was due to end of service of the 37714. The cause of the lead being stuck in the old implantable neurostimulator and not advancing into the new implantable neurostimulator was not determined. The lead is still implanted, and it is to be determined whether or not it can be used. It showed high impedances during intraop testing when it was advanced into the implantable neurostimulator as far as it would go. There were no patient symptoms or 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
david gustafson
7000 central avenue ne rcw215
minneapolis, MN 55432
7635149628
MDR Report Key10318243
MDR Text Key200439165
Report Number3004209178-2020-12749
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
Reporter Occupation
Type of Report Initial
Report Date 07/23/2020
1 Device Was Involved in the Event
0 PatientS WERE Involved in the Event:
Date FDA Received07/23/2020
Is This An Adverse Event Report? No
Is This A Product Problem Report? Yes
Device Operator HEALTH PROFESSIONAL
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 Received07/10/2020
Was Device Evaluated By Manufacturer? No Answer Provided
Date Device Manufactured05/05/2020
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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