MAUDE Adverse Event Report: NEURO - VILLALBA; STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR

Model Number	3708240
Medical Device Problem Code	Impedance Problem (2950)
Health Effect - Clinical Code	Loss of Range of Motion (2032)
Date of Event	09/21/2021
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.
Event or Problem Description
The patient reported via the manufacturer representative that they had a limited range of motion in the neck.The patient had their implant battery replaced last week due to normal battery depletion and the subsequent reposition of the lead-extension connection resulted in the limited range of motion.A revision was performed on 27-sep to position the connectors again to provide more slack in the system.An impedance check showed a warning for the 8-9 electrode pair.The issue was resolved at the time of the report and a follow-up was going to be done to ensure no programming was needed to accommodate the impedance issue.

• Brand Name: NA
• Common Device Name: STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR
• Manufacturer (Section D): NEURO - VILLALBA; call box 6001; villalba PR 00766
• MDR Report Key: 12555735
• Report Number: 6000153-2021-00053
• Device Sequence Number: 4584153
• Product Code: LGW
• UDI-Device Identifier: 00885074404516
• UDI-Public: 00885074404516
• Combination Product (Y/N): N
• Initial Reporter State: IL
• Initial Reporter Country: US
• PMA/510(K) Number: P840001
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2013
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,consum
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 09/30/2021

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: 04/06/2015
• Device Model Number: 3708240
• Device Catalogue Number: 3708240
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/24/2021
• Initial Report FDA Received Date: 09/30/2021
• 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: Required Intervention
• Patient Age: 50 YR
• Patient Weight: 59