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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 Problems Break (1069); Electromagnetic Interference (1194); High impedance (1291)
Patient Problems Pain (1994); Burning Sensation (2146)
Event Date 10/01/2019
Event Type  Injury  
Manufacturer Narrative
Concomitant medical products: product id: 37713, lot# serial# (b)(4), implanted: (b)(6) 2011, explanted: (b)(6) 2019, product type: implantable neurostimulator. Product id: 3888-45, lot#: v588266, implanted: (b)(6) 2011, product type: lead. Product id: 3888-45, lot#: v568713, implanted: (b)(6) 2011, product type: lead. Product id: 3777-75, serial#: (b)(4), implanted: (b)(6) 2011, product type: lead. Product id: 3888-45, serial/lot #: (b)(4), ubd: 12-nov-2014, udi#: (b)(4). Product id: 3888-45, serial/lot #: (b)(4), ubd: 19-oct-2014, udi#: (b)(4). Product id: 3777-75, serial/lot #: (b)(4), ubd: 10-mar-2014, udi#: (b)(4). If information is provided in the future, a supplemental report will be issued.
 
Event Description
It was reported that on (b)(6) 2019 the patient was admitted to the hospital with complaints of ongoing lumbar back pain around her spinal stimulation and abdominal pain as well as a burning pain radiating down her bilateral legs from the site of her stimulator. The patient was examined on (b)(6) 2019 by the healthcare provider (hcp) and requested a manufacturer's representative (rep) to discuss the spinal stimulator before making a decision. A rep evaluated the patient on (b)(6) 2019 and found the inss life span was to end in (b)(6) 2020. The rep also told the patient it was safe for her to undergo an mri even though the stimulator was not mri compatible. It was decided on (b)(6) 2019 to change the ins out to an mri compatible battery which the hcp believed would allow the patient to safely undergo an mri. The patient underwent a revision and replacement of the ins on (b)(6) 2019.  the hcp replaced the ins but not the leads. The patient later underwent an mri on (b)(6) 2019 of the lumbar spine without contrast during which the patient experienced burning pain in her neck and back as well as at the peripheral lead sites. The patient was informed on (b)(6) 2019 that the hcp did not change the leads on the ins when the ins was replaced and the leads were not mri compatible. The hcp did not replace the leads at the time the ins was replaced because it was not his specialty. On (b)(6) 2020 the patient underwent surgery to have the entire system, ins and leads removed due to ongoing pain. After the surgery, the patient was informed that the leads were damaged, fractured, singed and one lead had snapped. (b)(6) 2021 legal, legal 1, legal 2: no new information.
 
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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 Key11605550
MDR Text Key251349160
Report Number3004209178-2021-05359
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 04/01/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received04/01/2021
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date03/28/2020
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 Received03/17/2021
Was Device Evaluated by Manufacturer? No Answer Provided
Date Device Manufactured03/28/2019
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: 04/01/2021 Patient Sequence Number: 1
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