• 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 Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problems Abdominal Pain (1685); Hematoma (1884); Hemorrhage/Bleeding (1888); Paraplegia (2448)
Event Date 10/30/2019
Event Type  Injury  
Manufacturer Narrative
Concomitant medical products: product id 977c165, serial# (b)(4), implanted: (b)(6) 2019, product type lead. If information is provided in the future, a supplemental report will be issued.
 
Event Description
Information was received from a healthcare professional via manufacturer representative, regarding a patient who was implanted with a neurostimulator (ins). It was reported that an er physician called to report that patient came to er with abdominal pain and while he was there he became paraplegic. Patient needed emergent mri but did not have his scs remote with him. The cause was unknown. Rep confirmed that stimulation has not yet been turned on and that all implanted devices are full body conditional for mri. The hcp decided to proceed with mri without the device being put into mri mode. Patient's weight was asked but unknown. No further complications were reported.
 
Manufacturer Narrative
Product id 977c165, serial# (b)(4), implanted: (b)(6) 2019, explanted: (b)(6) 2019, product type: lead. If information is provided in the future, a supplemental report will be issued.
 
Event Description
Additional information was received from the rep. It was reported that the cause of the abdominal pain/patient became paraplegic was subdural hematoma compressing the spinal cord. There were no direct device issues. Devices were explanted on 10/31. It was unknown if the symptoms were resolved. The provided information was confirmed with physician/account.
 
Manufacturer Narrative
Product id: 977c165, serial# (b)(4), implanted: (b)(6) 2019, explanted: (b)(6) 2019, product type: lead; product id: 977c165, serial# (b)(4), implanted: (b)(6) 2019, explanted: (b)(6) 2019, product type: lead. If information is provided in the future, a supplemental report will be issued.
 
Event Description
Additional information was received from a healthcare provider (hcp) via a manufacturer¿s representative (rep). The rep reported that per the hcp, the patient developed a hematoma at the site of the paddle lead placement as well as a gi bleed. There were no known environmental/external/patient factors that could have led to the issue. The rep reported that there was an mri and physical assessment of the patient by the hcp on (b)(6) 2019. The rep reported that the system was removed on (b)(6) 2019. The issue was resolved. No further complications were reported.
 
Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.
 
Event Description
Additional information was received from the rep. It was reported that the customer discarded the device. It was unknown if the symptoms resolved after the explant. The provided information was confirmed with the physician/account. No further complications were reported.
 
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 Key9265608
MDR Text Key164812225
Report Number3004209178-2019-20855
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,health
Reporter Occupation
Type of Report Initial,Followup,Followup,Followup
Report Date 12/11/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received11/01/2019
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Expiration Date07/28/2020
Device Model Number97715
Device Catalogue Number97715
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received11/21/2019
Was Device Evaluated by Manufacturer? No Answer Provided
Date Device Manufactured08/09/2019
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: 11/01/2019 Patient Sequence Number: 1
-
-