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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 Problem Appropriate Term/Code Not Available (3191)
Patient Problem Erosion (1750)
Event Date 04/17/2019
Event Type  Injury  
Manufacturer Narrative
Concomitant medical products: product id: 977a260, serial# (b)(4), implanted: (b)(6) 2018, product type: lead; product id: 977a260, serial# (b)(4), implanted: (b)(6) 2018, product type: lead. Other relevant device(s) are: product id: 977a260, serial/lot #: (b)(4), ubd: 15-oct-2022, udi#: (b)(4); product id: 977a260, serial/lot #: (b)(4), ubd: 02-oct-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 representative (rep), regarding a patient with an implantable neurostimulator (ins) for spinal pain. It was reported that the leads were very visible under the patient's skin. The healthcare professional (hcp) was concerned the leads may have pushed through the skin. Per the hcp, the patient was advised not to return to physical therapy until released by the hcp, however the patient returned to physical therapy prior to being released. The hcp thought the suture may have come out/came loose but the leads were still intact. The hcp decided to add a suture to keep the leads flush under skin and not protrude. The rep noted that there were no issues with the functionality of leads and the leads were not revised, only a suture was added. It was noted that the issue was resolved at the time of the report. No further complications were reported/anticipated.
 
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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 Key8549816
MDR Text Key143078561
Report Number3004209178-2019-08258
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
Report Date 04/25/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received04/25/2019
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date09/28/2019
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 Received04/17/2019
Was Device Evaluated by Manufacturer? No Answer Provided
Date Device Manufactured10/07/2018
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: 04/25/2019 Patient Sequence Number: 1
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