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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

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MEDTRONIC PUERTO RICO OPERATIONS CO. INTELLIS STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR Back to Search Results
Model Number 97715
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problems Erythema (1840); Unspecified Infection (1930); No Clinical Signs, Symptoms or Conditions (4582)
Event Date 08/03/2022
Event Type  Injury  
Manufacturer Narrative
Concomitant medical products: product id 977a260 lot# serial# (b)(4) implanted: (b)(6) 2022 explanted: (b)(6) 2022 product type lead. Product id 977a260 lot# serial# (b)(4) implanted: (b)(6) 2022 explanted: (b)(6) 2022 product type lead. Other relevant device(s) are: product id: 977a260, serial/lot #: va2l6ud019, ubd: 17-apr-2026, udi#: 00763000324278 ; product id: 977a260, serial/lot #: (b)(4), ubd: 17-apr-2026, udi#: (b)(4). Medtronic is submitting this report to comply with fda reporting regulations under 21 cfr parts 4 and 803. This report is based upon information obtained by medtronic, which the company may not have been able to fully investigate or verify prior to the date the report was required by the fda. Medtronic has made reasonable efforts to obtain more complete information and has provided as much relevant information as is available to the company as of the submission date of this report. This report does not constitute an admission or a conclusion by fda, medtronic, or its employees that the device, medtronic, or its employee caused or contributed to the event described in the report. In particular, this report does not constitute an admission by anyone that the product described in this report has any ¿defects¿ or has ¿malfunctioned¿. These words are included in the fda 3500a form and are fixed items for selection created by the fda to categorize the type of event solely for the purpose of regulatory reporting. Medtronic objects to the use of these words and others like them because of the lack of definition and the connotations implied by these terms. This statement should be included with any information or report disclosed to the public under the freedom of information act. Any required fields that are unpopulated are blank because the information is currently unknown or unavailable. A good faith effort will be made to obtain the applicable information relevant to the report. 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 spinal pain indications. The caller reported that the patient was recently implanted with the scs ins and a tyrx pouch was used. The caller reported that the patient developed redness at the pocket site. The healthcare provider determined that the patient had an infection, they confirmed the patient had an elevated sed rate. Tyrx pouch lot number: r155298. Troubleshooting was not required and the issue was not resolved through troubleshooting. Information about infection was reviewed. The caller stated that the hcp plans to perform an explant of the scs system on (b)(6) 2022 and monitor the patient.
 
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Brand NameINTELLIS
Type of DeviceSTIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR
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
glen belmer
7000 central avenue ne rcw215
minneapolis, MN 55432
6122713209
MDR Report Key15175990
MDR Text Key297347058
Report Number3004209178-2022-09966
Device Sequence Number1
Product Code LGW
UDI-Device Identifier00763000315467
UDI-Public00763000315467
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 Non-Healthcare Professional
Type of Report Initial,Followup
Report Date 08/11/2022
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received08/05/2022
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Model Number97715
Device Catalogue Number97715
Was Device Available for Evaluation? No
Date Manufacturer Received08/05/2022
Was Device Evaluated by Manufacturer? No Answer Provided
Date Device Manufactured05/23/2022
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: 08/05/2022 Patient Sequence Number: 1
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