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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 Migration or Expulsion of Device (1395); Patient Device Interaction Problem (4001)
Patient Problems Bruise/Contusion (1754); Unspecified Infection (1930); Pain (1994); Skin Erosion (2075)
Event Date 10/26/2019
Event Type  Injury  
Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.
 
Event Description
Additional information was received from the patient. The patient reported that it started turning in the pocket and was rubbing and built up a ridge and broke through the skin. The patient reported that surgery was set for (b)(6) 2019. No further complications were reported.
 
Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.
 
Event Description
Information was received from a patient who was implanted with an implantable neurostimulator (ins) for failed back surgery syndrome and spinal pain. The patient reported that her ins was sticking out of her skin and was causing pain. The patient reported that this was the left ins and this seemed as though the battery had slipped out and pressing up against the top layer of skin. The patient reported that it was hitting skin and hurts. The patient reported that her husband said the site was black and blue, looked like it was breaking through the skin. The patient reported that she bumped into a doorway and after that its all started to do this. 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 patient via a manufacturer representative (rep) reporting that the patient complained their battery seemed to be protruding and made an appointment with their doctor on (b)(6) 2019 where they discovered that part of the battery was in fact protruding from the skin. An infection was reported. The cause of the issue was unknown. The doctor removed the battery on (b)(6) 2019 and would be scheduling a replacement. The issue was not resolved at the time of the report. The customer discarded the explanted battery, so it will not be returned for analysis. The rep indicated that they would obtain additional information from the healthcare provider (hcp) on 2020-02-22. No further complications were reported/anticipated.
 
Manufacturer Narrative
Product id: 3778-60, serial# (b)(4), implanted: (b)(6) 2009, product type: lead; product id: 3778-60, serial# (b)(4), implanted: (b)(6) 2009, product type: lead. If information is provided in the future, a supplemental report will be issued.
 
Event Description
Additional information received from a manufacturer representative (rep). It was reported that one of the leads migrated down. The device was able to stimulate the areas needed with the other lead, so no other further action was needed at this time. No further complications were reported.
 
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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 Key9398570
MDR Text Key177899904
Report Number3004209178-2019-22901
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,Followup,Followup
Report Date 03/03/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received12/02/2019
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date01/28/2019
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 Received02/07/2020
Was Device Evaluated by Manufacturer? No Answer Provided
Date Device Manufactured02/05/2018
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: 12/02/2019 Patient Sequence Number: 1
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