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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 Adverse Event Without Identified Device or Use Problem (2993)
Patient Problems Local Reaction (2035); Seroma (2069); Fluid Discharge (2686)
Event Type  Injury  
Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.
 
Event Description
Information was received from a manufacturer representative regarding a patient who was implanted with an implantable neurostimulator (ins) for non-malignant pain. It was reported that patient had a pocket revision done. Reports patient has a history of lupus. The original pocket physician used tyrx and unknown if the pocket revision is related to tyrx. Patient had about ½ to 1-inch trim off the ins pocket site, shape of an oval. Caller did not know if the site was infected, culture was sent for analyze. When the pocket was open, there were clear fluid inside the pocket, the wound was outside the pocket. The spine incision looks intact, just the ins pocket site was affected. Unknown if antibiotic was started. This pocket revision, physician did not use tyxr this time. Additional information was received from the rep. It was reported that cultures came back negative. The report of lupus was a misunderstanding. Patient does not have lupus. It was suspected in the past but rep confirmed today patient does not have lupus. Tests for lupus were negative in the past. It could not be confirmed if pocket issues were related to tyrx. Actions/interventions taken to resolve the issue after the revision were that physician cut off the irritated tissue. On (b)(6), at patient's post op; the incision and the pocket site looked healthy and great. Staples will be removed next tuesday (b)(6). The issue was resolved and patient recovered. Nothing was explanted.
 
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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
david gustafson
7000 central avenue ne rcw215
minneapolis, MN 55432
7635149628
MDR Report Key11381390
MDR Text Key233795176
Report Number3004209178-2021-03270
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
Reporter Occupation
Type of Report Initial
Report Date 02/25/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received02/25/2021
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
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 Received02/10/2021
Was Device Evaluated by Manufacturer? No Answer Provided
Date Device Manufactured12/09/2020
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: 02/25/2021 Patient Sequence Number: 1
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