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

Model Number 97715

Device Problem Break (1069)

Patient Problem Sepsis (2067)

Event Date 06/12/2019

Event Type  Injury  

Manufacturer Narrative

Concomitant medical products: product id: 977a260, serial #: (b)(4), implanted: (b)(6) 2018, product type: lead.Product id: 977a260, serial #: (b)(4), implanted: (b)(6) 2018, product type: lead.Other relevant device(s) are: product id: 977a260, serial/lot #: (b)(4), ubd: 02-feb-2022, udi #: (b)(4).Product id: 977a260, serial/lot #: (b)(4), ubd: 02-feb-2022, udi #: (b)(4).If information is provided in the future, a supplemental report will be issued.

Event Description

Information was received from a healthcare professional (hcp), via a manufacturer representative (rep), regarding a patient with an implantable neurostimulator (ins) for non-malignant pain.It was reported that the patient was hospitalized after becoming ill with sepsis.The rep said a ct and x-ray showed one lead to be fractured.It was unknown what factors may have led to the issue.The rep noted that the patient was out of state in a hospital, it was unknown if surgical intervention was planned and the issue had not been resolved at the time of the report.The rep said they would follow-up with the hcp on jun-25.No further complications were reported.

Manufacturer Narrative

Product id 977a260, serial# (b)(4), implanted: (b)(6) 2018, product type: lead.Product id 977a260, serial# (b)(4), implanted: (b)(6) 2018, product type: lead.If information is provided in the future, a supplemental report will be issued.

• 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: 8697049
• MDR Text Key: 147950534
• Report Number: 3004209178-2019-11563
• 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: Other
• Type of Report: Initial,Followup
• Report Date: 08/16/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/13/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 01/28/2019
• Device Model Number: 97715
• Device Catalogue Number: 97715
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 08/16/2019
• Date Device Manufactured: 01/31/2018
• 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): Hospitalization; Life Threatening; Other
• Patient Age: 64 YR