Barostim Neo2
Received Jul 28, 2026 · Event occurred Jun 29, 2026
Report 3007972010-2026-00089 · MDR key 50057096
Product problems
- Material Split, Cut or Torn
Patient
Not reported
- No Clinical Signs, Symptoms or Conditions
Narrative
Description of Event or Problem
A Barostim system was implanted on (b)(6) 2023. During a planned normal replacement on (b)(6) 2026, the surgeon confirmed both set screws had been fully backed out by visual inspection of the header and directly into the screw ports, the lead plug was withdrawn smoothly, but the lead pin remained firmly retained within the header and could not be removed. Dry gauze was used to improve the grip on the lead pin but was not successful. The header was inspected for dried blood or any material that could contribute to retention but no obstruction was observed. Saline was attempted as a means to removal to no avail. A screwdriver from a different manufacturer was used to confirm the set screws were removed but no change to lead retention was observed. The surgeon continued attempts to remove the lead from the header, during which time the silicone insolation was stripped from the lead body. The lead was cut and capped and the procedure was aborted. It was noted that approximately 10-12 minutes was spent attempting to remove the lead. The patient was hospitalized overnight for observation and discharged the next day without issue. Another procedure to implant a new Barostim system was planned but not yet scheduled.
Additional Manufacturer Narrative
IPG Device Information: Serial Number: (b)(6), Model Number: 2102, Part Number: 100054-202, Manufacture Date: 2022-08-16, Exp Date: 2024-08-16, UDI: (b)(4). Analysis of the reported device is in progress. A supplemental report will be submitted when the device analysis is completed.ID#: (b)(4).