MAUDE Adverse Event Report: MEDTRONIC NEUROMODULATION INTELLIS; STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF

Model Number	97725
Medical Device Problem Code	Migration or Expulsion of Device (1395)
Health Effect - Clinical Codes	Purulent Discharge (1812); Unspecified Infection (1930)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Concomitant medical products: product id: 977d260, serial#: (b)(4), implanted: (b)(6) 2018, product type: screening device.Product id: 977d260, serial#: (b)(4), implanted: (b)(6) 2018, product type: screening device.Other relevant device(s) are: product id: 977d260, serial/lot #: (b)(4), ubd: 07/03/2022, udi#: (b)(4); product id: 977d260, serial/lot #: (b)(4), ubd:07/20/2022, udi#: (b)(4).If information is provided in the future, a supplemental report will be issued.
Event or Problem Description
10/18/2018 information was received from a healthcare professional via manufacturer representative, regarding a stim trial patient.It was reported that patient stopped returning phone calls after first five days of stim trial.He did not respond to repeated calls from the rep or the physician's office.After approximately three weeks of no responses, the police were dispatched to his listed address and a register letter sent to a post office box.The rep got patient on the phone at approximately 1 month after the surgery date.Patient immediately hung up the phone and would not respond to additional calls.Judge in the workers comp case ordered the patient to report to the physician¿s office.At that court ordered appointment, patient indicated puss formed at the incision site and reports he went to the er.Patient presented the leads saying they fell out.It is believed that any infection, if it occurred as reported, was due to the lack of patient compliance.The devices were discarded by the customer.Patient's weight was asked but unknown.The issue was resolved at the time of the report.The event date was unknown.No further complications were reported/anticipated.

• Brand Name: INTELLIS
• Common Device Name: STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF
• Manufacturer (Section D): MEDTRONIC NEUROMODULATION; 800 53rd ave ne; minneapolis MN 55421 1200
• MDR Report Key: 7990300
• Report Number: 3007566237-2018-03092
• Device Sequence Number: 1488137
• Product Code: LGW
• UDI-Device Identifier: 00613994925961
• UDI-Public: 00613994925961
• Combination Product (Y/N): N
• Initial Reporter State: NJ
• Initial Reporter Country: US
• PMA/510(K) Number: P840001
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 10/22/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 12/07/2019
• Device Model Number: 97725
• Device Catalogue Number: 97725
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/18/2018
• Initial Report FDA Received Date: 10/22/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Age: 29 YR