MAUDE Adverse Event Report: MEDTRONIC PUERTO RICO OPERATIONS CO. INTELLIS; STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF

Model Number 97715

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Abdominal Pain (1685); Hematoma (1884); Hemorrhage/Bleeding (1888); Paraplegia (2448)

Event Date 10/30/2019

Event Type  Injury  

Manufacturer Narrative

Concomitant medical products: product id 977c165, serial# (b)(4), implanted: (b)(6) 2019, product type lead.If information is provided in the future, a supplemental report will be issued.

Event Description

Information was received from a healthcare professional via manufacturer representative, regarding a patient who was implanted with a neurostimulator (ins).It was reported that an er physician called to report that patient came to er with abdominal pain and while he was there he became paraplegic.Patient needed emergent mri but did not have his scs remote with him.The cause was unknown.Rep confirmed that stimulation has not yet been turned on and that all implanted devices are full body conditional for mri.The hcp decided to proceed with mri without the device being put into mri mode.Patient's weight was asked but unknown.No further complications were reported.

Manufacturer Narrative

Product id 977c165, serial# (b)(4), implanted: (b)(6) 2019, explanted: (b)(6) 2019, product type: lead.If information is provided in the future, a supplemental report will be issued.

Event Description

Additional information was received from the rep.It was reported that the cause of the abdominal pain/patient became paraplegic was subdural hematoma compressing the spinal cord.There were no direct device issues.Devices were explanted on 10/31.It was unknown if the symptoms were resolved.The provided information was confirmed with physician/account.

Manufacturer Narrative

Product id: 977c165, serial# (b)(4), implanted: (b)(6) 2019, explanted: (b)(6) 2019, product type: lead; product id: 977c165, serial# (b)(4), implanted: (b)(6) 2019, explanted: (b)(6) 2019, product type: lead.If information is provided in the future, a supplemental report will be issued.

Event Description

Additional information was received from a healthcare provider (hcp) via a manufacturer¿s representative (rep).The rep reported that per the hcp, the patient developed a hematoma at the site of the paddle lead placement as well as a gi bleed.There were no known environmental/external/patient factors that could have led to the issue.The rep reported that there was an mri and physical assessment of the patient by the hcp on (b)(6) 2019.The rep reported that the system was removed on (b)(6) 2019.The issue was resolved.No further complications were reported.

Manufacturer Narrative

If information is provided in the future, a supplemental report will be issued.

Event Description

Additional information was received from the rep.It was reported that the customer discarded the device.It was unknown if the symptoms resolved after the explant.The provided information was confirmed with the physician/account.No further complications were reported.

• Brand Name: INTELLIS
• Type of Device: STIMULATOR, 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: lisa woodward clark ; 7000 central avenue ne rcw215; minneapolis, MN 55432 ; 7635263920
• MDR Report Key: 9265608
• MDR Text Key: 164812225
• Report Number: 3004209178-2019-20855
• Device Sequence Number: 1
• Product Code: LGW
• UDI-Device Identifier: 00643169781702
• UDI-Public: 00643169781702
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P840001
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup,Followup
• Report Date: 12/11/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/01/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 07/28/2020
• Device Model Number: 97715
• Device Catalogue Number: 97715
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 11/21/2019
• Date Device Manufactured: 08/09/2019
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Other; Required Intervention
• Patient Age: 81 YR