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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: MEDTRONIC NEUROMODULATION INTELLIS STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR

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MEDTRONIC NEUROMODULATION INTELLIS STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR Back to Search Results
Model Number 97725
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problems Erythema (1840); Hypersensitivity/Allergic reaction (1907); Unspecified Infection (1930); Inflammation (1932); Itching Sensation (1943)
Event Date 03/15/2021
Event Type  Injury  
Manufacturer Narrative
Concomitant medical products: product id: neu_unknown_lead, serial#: unknown, explanted: (b)(6) 2021, product type: lead. Other relevant device(s) are: product id: neu_unknown_lead, serial/lot #: unknown. If information is provided in the future, a supplemental report will be issued.
 
Event Description
Information was received from multiple sources (healthcare provider, clinical study) regarding a patient who was trialing a spinal cord stimulation system. It was reported that the patient was trialing a spinal cord stimulation system. On (b)(6) 2021, the patient reported itching under surgery bandages. There was an unscheduled emergency room visit on (b)(6) 2021. There was redness involving all area under tegaderm and gauze. An allergic reaction around the lumbar site was diagnosed. The spinal cord stimulation leads were removed in tact on (b)(6)2021, and the patient was prescribed polysporin and keflex.  skin irritation was still present on (b)(6) 2021 at their office visit. The patient denied a rash as of (b)(6) 2021, and it was noted that this event was resolved.
 
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Brand NameINTELLIS
Type of DeviceSTIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR
Manufacturer (Section D)
MEDTRONIC NEUROMODULATION
7000 central ave ne
minneapolis MN 55432
Manufacturer (Section G)
MEDTRONIC NEUROMODULATION
7000 central ave ne
minneapolis MN 55432
Manufacturer Contact
glen belmer
7000 central avenue ne rcw215
minneapolis, MN 55432
6122713209
MDR Report Key12478811
MDR Text Key277455057
Report Number2182207-2021-01583
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,health
Reporter Occupation
Type of Report Initial,Followup
Report Date 10/14/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received09/15/2021
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Model Number97725
Device Catalogue Number97725
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received09/20/2021
Was Device Evaluated by Manufacturer? No Answer Provided
Date Device Manufactured02/10/2021
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Unkown

Patient Treatment Data
Date Received: 09/15/2021 Patient Sequence Number: 1
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