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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 Problem Unspecified Infection (1930)
Event Date 10/21/2021
Event Type  Injury  
Manufacturer Narrative
Concomitant products: product id: 3708140, serial#: (b)(4), implanted: (b)(6) 2018, explanted: (b)(6) 2021, product type: extension. Product id: 3708140, serial#: (b)(4), implanted: (b)(6) 2013 , explanted: (b)(6) 2021, product type: extension, product id: 3708140, serial#: (b)(4), implanted: (b)(6) 2013, explanted: (b)(6) 2021, product type: extension. Product id: 39286-65, serial#: (b)(4), implanted: (b)(6) 2013, explanted: (b)(6) 2021, product type: lead. Other relevant device(s) are: product id: 3708140, serial/lot #: (b)(4), ubd: 25-aug-2021, udi#: (b)(4); product id: 3708140, serial/lot #: (b)(4), ubd: 05-apr-2017, udi#: (b)(4); product id: 3708140, serial/lot #: (b)(4), ubd: 05-apr-2017, udi#: (b)(4); product id: 39286-65, serial/lot #: (b)(4), ubd: 26-aug-2017, udi#: (b)(4). If information is provided in the future, a supplemental report will be issued.
 
Event Description
Information was received from multiple sources (manufacturer representative, healthcare provider) regarding a patient who was implanted with an implantable neurostimulator (ins). It was reported that during an intra-operative procedure to remove the patient's (pt) lead and extensions to replace with an mri compatible lead, upon opening at the cervical incision area, there appeared to be an infection. Therefore the physician ended up explanting the entire system. Once patient is healed, a new system will be implanted at that time.
 
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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 Key12698006
MDR Text Key278382417
Report Number3004209178-2021-15902
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
Report Date 10/26/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received10/26/2021
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Expiration Date01/14/2019
Device Model Number97715
Device Catalogue Number97715
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 Received10/21/2021
Was Device Evaluated by Manufacturer? No Answer Provided
Date Device Manufactured01/24/2018
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: 10/26/2021 Patient Sequence Number: 1
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