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Terminated

Medtronic 3777 Lead Kit, 1x8 Low Impedance Lead Kit for Spinal Cord Stimulation (SCS). Manufactured at: Medtronic, Inc., Villalba, Puerto Rico USA. Medtronic, Inc., Minneapolis, MN 55432-5604.

FDA Recall Z-1536-06 · Posted 2006-09-29

Recalling FirmMedtronic Neurological
Recall StatusTerminated
Product CodeLGW
Date Initiated2006-08-02
Date Terminated2006-12-31
Product Quantity22 total

Reason for Recall

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.

Firm 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.

Root Cause

Other

Distribution Pattern

Nationwide distribution --- including states of CA, GA, KY, LA, and TX.

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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