• Decrease font size
  • Return font size to normal
  • Increase font size
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

  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 

MEDTRONIC PUERTO RICO OPERATIONS CO. INTELLIS STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF Back to Search Results
Model Number 97715
Device Problems Failure to Deliver Energy (1211); High impedance (1291); Unable to Obtain Readings (1516)
Patient Problems Therapeutic Effects, Unexpected (2099); No Known Impact Or Consequence To Patient (2692)
Event Date 06/13/2018
Event Type  Injury  
Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.
 
Event Description
Information was received from a manufacturer¿s representative (rep) regarding a patient who was implanted with an implantable neurostimulator (ins) for non-malignant pain. The rep reported that they were running the check connectivity function and was getting all red x¿s. The rep reported that the ins was being replaced due to normal end of life (eol). The battery was depleted at the time of the case today, so impedances couldn¿t be run prior to replacement. The rep reported that the healthcare provider (hcp) originally placed the lead in the top channel of the ins and got all red x¿s. The hcp then moved the lead to the bottom channel and again she got all red x¿s on the check connectivity function. The rep reported that she programmed two 1x8 leads to ensure the ins would test all electrodes. The rep reported that she ran a full impedance test and got all electrodes at greater than 40,000 ohms. It was reviewed to remove, wipe and reinsert the lead into the ins to try and resolve the impedance issue and then test in a multi-lead trialing cable (mltc) or wireless external neurostimulator (wens) and if the impedances were still out of range, the lead would likely need to be replaced. The rep tested with the mltc and all impedances were over 40,000 ohms when tested at 3v. The rep reported that they looked at the x-ray and c arm which didn¿t show any break. The rep also reported that the patient claimed to be getting stimulation when they came in for the replacement. No further complications were reported.
 
Manufacturer Narrative
Product id: 3778-60, serial# (b)(4), implanted: (b)(6) 2009, explanted: (b)(6) 2018, product type: lead. If information is provided in the future, a supplemental report will be issued.
 
Event Description
Additional information was received from the manufacturing representative (rep). The rep reported that the patient¿s stimulation was not working properly for several months. They stated that during the patient¿s battery replacement procedure, impedances were taken, and all electrodes were greater than 10,000 ohms. The cause of the issue was not determined. The rep indicated that impedances were checked again after the lead was connected to the new battery, and impedances showed greater than 10,000 ohms. The lead was then connected to a multi-lead trialing cable (mltc); impedances were greater than 10,000 ohms. The rep stated that the 3778 lead was then replaced with a 977a260. When the replacement lead was connected to the new battery, the system worked properly. The issue was resolved at the time of the report. The rep was to return the explanted lead for analysis. No further complications were reported or anticipated.
 
Manufacturer Narrative
Analysis results were not available at the time of this report. A follow up report will be sent once analysis is complete. Concomitant medical products: product id: 3778-60, (b)(4), implanted: (b)(6) 2009, explanted: (b)(6) 2018, product type: lead. If information is provided in the future, a supplemental report will be issued.
 
Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.
 
Manufacturer Narrative
Analysis of the lead ((b)(4)) found the stim lead body conductors were broken 14. 4cm from the distal end at the titan anchor site. Product id: 3778-60, serial# (b)(4), implanted: (b)(6) 2009, explanted: (b)(6) 2018, product type: lead; product id 3550-39, serial# unknown, product type: accessory. If information is provided in the future, a supplemental report will be issued.
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

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 Key7607145
MDR Text Key111443732
Report Number3004209178-2018-13578
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,Followup,Followup,Followup,Followup
Report Date 10/05/2018
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received06/15/2018
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date05/28/2019
Device Model Number97715
Device Catalogue Number97715
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer06/25/2018
Is the Reporter a Health Professional? No
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received08/08/2018
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured05/31/2018
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: 06/15/2018 Patient Sequence Number: 1
-
-