Potential Delayed Restoration of Permanent Settings
Minix and Minix ST IPGs
Original Date of Communication:
May 1991
View specific models that this applies to
Product
All Models of the Minix and Minix ST families of implantable pulse generators
Advisory
Possibility of delayed restoration of permanent pacing mode and parameters, after the magnet or programming head is removed under certain conditions.
Patient Management Recommendations
To eliminate any potential risk associated with temporary programming, depress the INTERROGATE key and verify successful interrogation before moving the programming head away from the pulse generator. The delay condition can also be terminated by repositioning the programming head and depressing the EMERGENCY VVI key.
Status Update
Device performance related to this advisory continues to be within Medtronic’s engineering projections. Patient management recommendations remain unchanged. Out of the initial implant population of 65,000 in the United States, approximately 2,000 remain implanted. The devices affected by this advisory are nearing the end of their expected longevity.
| Initial Affected Population | Estimated Remaining Active Population |
To eliminate any potential risk associated with temporary programming, depress the INTERROGATE key and verify successful interrogation before moving the programming head away from the pulse generator. |
| All Minix and Minix ST implantable pulse generators | 2,000 (United States) |