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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 Degraded (1153); High impedance (1291)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 02/24/2021
Event Type  Malfunction  
Manufacturer Narrative

Concomitant medical products: product id: 3777-60, serial#: (b)(4), implanted: (b)(6) 2012, product type: lead. Product id: 3777-60, serial#: (b)(4), implanted: (b)(6) 2012, product type: lead. Product id: 3777-60, serial/lot #: (b)(4), ubd: 12-mar-2016, udi#: (b)(4). Product id: 3777-60, serial/lot #: (b)(4), ubd: 02-dec-2015, udi#: (b)(4). If information is provided in the future, a supplemental report will be issued.

 
Event Description

It was reported that the patient was undergoing a replacement of the implantable neurostimulator on (b)(6) 2021 when the 0-7 lead was pushed all the way into the new implantable neurostimulator. All electrodes had greater than 40,000 ohm impedances. The health care professional tried wiping and reinserting the lead and the health care professional noted that the lead seemed "corroded. " when the health care professional pulled the lead out 1 contact, they lost contact 7, but the remaining contacts 0-6 no longer had high impedances. The health care professional decided to lose the one contact rather than replace the lead. They were going to program around contact 7.

 
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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 Key11378764
MDR Text Key233506755
Report Number3004209178-2021-03241
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 02/25/2021
1 Device Was Involved in the Event
0 PatientS WERE Involved in the Event:
Date FDA Received02/25/2021
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 Received02/24/2021
Was Device Evaluated By Manufacturer? No Answer Provided
Date Device Manufactured12/30/2020
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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