—#203871

Product

Model 97745 Controller used with Models 97715 and 97716 Intellis Neurostimulators

FDA product code: LGW — Stimulator, Spinal-Cord, Totally Implanted For Pain Relief
Device class: Class 3
Medical specialty: Unknown
Affected lot / code info: UDI/DI 00763000642297, Serial Numbers: NLD172060N, NLD142952N, NLD172064N, NLD142947N, NLD142942N, NLD172061N, NLD172062N, NLD172063N, NLD172066N; UDI/DI 00763000724436, Serial Numbers: NLD160337N, NLD163006N, NLD142943N, NLD163007N, NLD142944N, NLD163008N, NLD160338N, NLD163009N, NLD160339N, NLD163010N, NLD160340N, NLD163011N

Why it was recalled

Units distributed in Korea and Turkey that did not have the correct firmware installed to support the user interface in the local language.

Root cause (FDA determination)

Software Manufacturing/Software Deployment

Action the firm took

Medtronic issued an URGENT: MEDICAL DEVICE RECALL notice to its consignees via regionally approved method beginning 10/19/2023. The notice explained the issue, potential risk to the patient, and requested the return of the units.

Recalling firm

Firm: Medtronic Neuromodulation
Address: 7000 Central Ave Ne, Minneapolis, Minnesota 55432-3568

Distribution

Distribution pattern: International distribution to the countries of S. Korea and Turkey.

Timeline

Recall initiated: 2023-10-19
Posted by FDA: 2023-11-20
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #203871. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.