Recall Z-0088-2010 ยท LNQ Intestinal Stimulator
Medtronic Neuromodulation
Medtronic Enterra Therapy, Gastric Electrical Stimulation System, consisting of model 3116 Enterra Therapy Neurostimulator and model 4351 Unipolar Intramuscular Lead. Medtronic, Inc., 710 Medtronic Parkway, Minneapolis, MN 55432-5604 USA. The Neurostimulator (implantable neurostimulator or INS) is a multiprogrammable device designed to deliver therapy through gastric electrical stimulatio
| Date | Oct 29, 2009 (initiated Aug 25, 2009) |
| Status | Terminated |
| Reason | Medtronic is in the process of updating the Enterra Therapy labeling to include information regarding the risks of bowel obstruction and/or perforation. Medtronic has received 15 reports since November 2002 of bowel obstruction and/or perforation of the bowel associated with Enterra Therapy System leads. Of the 15 reported events, 11 required surgical intervention (all patients recovered withou |
| Root cause | Device Design |
| Action | Medtronic Neuromodulation issued a "Medical Device Correction" letter beginning August 25, 2009 addressed to Healthcare Professionals. The letter described the Nature of the Issue, Scope, Potential Severity of the Issue, Enterra Therapy System labeling updating information warnings, Recommendations and other Additional Information. For further information, contact Medronic Neuromodulation Technical Services at 1-800-707-0933. |
| Quantity | 1909 (1095 US, 814 OUS) |
| Distribution | Worldwide Distribution. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.