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

Model Number	97725
Medical Device Problem Code	High impedance (1291)
Health Effect - Clinical Code	Cerebrospinal Fluid Leakage (1772)
Date of Event	01/18/2019
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Concomitant medical products: product id: 977d260, serial #: (b)(4), product type: screening device.Other relevant device(s) are: product id: 977d260, serial/lot #: (b)(4), ubd: 18-oct-2022, udi #: (b)(4).Device evaluated by mfr: analysis of the lead (serial# (b)(4)) found no anomalies.If information is provided in the future, a supplemental report will be issued.
Event or Problem Description
Information was received from an healthcare professional (hcp), via manufacturer representative (rep), regarding an scs trial patient.It was reported that intra-op, high impedances were noted on all contacts.The rep believed that the high impedances were due to a wet tap.They changed the needle and lead and the high impedances still remained.The hcp performed a blood patch and they left the scs off.The products were replaced and the issue was resolved at the time of the report.Additional information was received from the rep who reported the patient was doing well.Later, it was reported that there were high impedances on all contacts.The rep believed the cause of the issue was the wet tap.The rep changed the lead, needle, and wens.A blood patch was done and the rep went to a different level.The issue was resolved.No further complications were reported.

• 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: 8641973
• Report Number: 3007566237-2019-01168
• Device Sequence Number: 2354721
• Product Code: LGW
• UDI-Device Identifier: 00613994925961
• UDI-Public: 00613994925961
• Combination Product (Y/N): N
• Initial Reporter State: CA
• 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): 05/24/2019

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: 12/30/2019
• Device Model Number: 97725
• Device Catalogue Number: 97725
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/17/2019
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/18/2019
• Initial Report FDA Received Date: 05/24/2019
• 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: 62 YR