Recall Z-1537-06 ยท LGW Stimulator, Spinal-Cord, Totally Implanted For Pain Relief
Medtronic Neurological
Medtronic 3778 Lead Kit, 1x8 Compact Low Impedance Lead Kit for Spinal Cord Stimulation (SCS). Manufactured at: Medtronic, Inc., Villalba, Puerto Rico USA. Medtronic, Inc., Minneapolis, MN 55432-5604.
| Date | Sep 29, 2006 (initiated Aug 2, 2006) |
| Status | Terminated |
| Reason | Model 3777 Standard Octad Lead (Lot V009545) and Model 3778 Compact Octad Lead (Lot V009546) were mispackaged. The result of this error is that lead kits labeled 3777 lot V009545 may contain a 3778 compact-spaced lead, while those labeled 3778 lot V009546 may contain a 3777 standard-spaced lead. The result of this error is an overall increase or decrease of 14 mm in the electrode coverage. |
| Root cause | Other |
| Action | Medtronic representatives retrieved non-implanted devices. An Urgent Medical Device Recall letter was sent to physicians to describe the issue and patient management information. |
| Quantity | 22 total |
| Distribution | Nationwide distribution --- including states of CA, GA, KY, LA, and TX. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.