• 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 Migration or Expulsion of Device (1395)
Patient Problems Incontinence (1928); Pain (1994)
Event Type  Injury  
Manufacturer Narrative
Concomitant medical products: product id: 977a160, serial#: (b)(4), implanted: (b)(6) 2019, product type: lead. Product id: 977a260, serial#: (b)(4), implanted: (b)(6) 2019, product type: lead. Other relevant device(s) are: product id: 977a160, serial/lot #: (b)(4), ubd: 13-nov-2021, udi#: (b)(4). Product id: 977a260, serial/lot #: (b)(4), ubd: 13-jul-2023, udi#: (b)(4). If information is provided in the future, a supplemental report will be issued.
 
Event Description
Information was received from a consumer, via a manufacturer representative (rep), regarding a patient with an implantable neurostimulator (ins). It was reported that the patient had a pocket/lead revision due to the ins moving. The patient said the ins was replaced. Following the revision, the rep turned the stimulation on and the patient reported feeling some pain at the site of the implant. 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
david gustafson
7000 central avenue ne rcw215
minneapolis, MN 55432
7635149628
MDR Report Key10128246
MDR Text Key194500598
Report Number3004209178-2020-09859
Device Sequence Number1
Product Code LGW
Combination Product (y/n)N
PMA/PMN Number
P840001
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,consum
Reporter Occupation
Type of Report Initial,Followup
Report Date 06/09/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received06/08/2020
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
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?
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received06/08/2020
Was Device Evaluated by Manufacturer? No Answer Provided
Date Device Manufactured08/12/2019
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: 06/08/2020 Patient Sequence Number: 1
-
-