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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 Failure to Deliver Energy (1211); Migration or Expulsion of Device (1395); Appropriate Term/Code Not Available (3191)
Patient Problems Pain (1994); Therapeutic Effects, Unexpected (2099); Therapeutic Response, Decreased (2271)
Event Date 07/14/2014
Event Type  Injury  
Manufacturer Narrative
Concomitant medical products: product id: 977a260, lot/serial#: (b)(4), implanted: (b)(6) 2018, product type: lead. Product id: 977a260, lot/serial#: (b)(4), implanted: (b)(6) 2018, product type: lead. Product id: 977a260, serial/lot #: (b)(4), ubd: 07-jun-2022, udi#: (b)(4). Product id: 977a260, serial/lot #: (b)(4), ubd: 07-jun-2022, 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's representative (rep) regarding an implantable neurostimulator (ins) for the treatment of non-malignant pain. It was reported that the patient said their stimulation shifted from left to right and then they couldn't feel it, so a reprogramming was scheduled. The patient stated that they were not doing anything crazy as far as bending lifting or twisting. The patient presented at the reprogramming and all impedances were green and less than 900. The patient could feel stimulation when the left lead was turned up, but felt nothing when the right lead was turned up. The rep changed the pulse width and rate and ran up amplitude, but nothing was felt. The healthcare provider (hcp) brought the patient back for a fluoroscopy shot and it was noted the lead was pulled down and out of the epidural space based on location in ap. No intervention has occurred yet, but the plan seems to be to refer out for a paddle lead replacement. No further complications were reported or anticipated.
 
Manufacturer Narrative
Corrected information. If information is provided in the future, a supplemental report will be issued.
 
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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
lisa woodward clark
7000 central avenue ne rcw215
minneapolis, MN 55432
7635263920
MDR Report Key7721982
MDR Text Key115088080
Report Number3004209178-2018-16677
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,consum
Reporter Occupation
Type of Report Initial,Followup
Report Date 10/03/2018
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received07/26/2018
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date02/28/2019
Device Model Number97715
Device Catalogue Number97715
Was Device Available for Evaluation? No
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? No Answer Provided
Date Device Manufactured03/10/2018
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: 07/26/2018 Patient Sequence Number: 1
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