Recall Z-1836-2013— St. Jude Medical
Class II · Terminated
Class II FDA medical device recall by St. Jude Medical, initiated 2012-07-26, terminated 2015-08-21. FDA's recall record names no specific 510(k) clearance for this event. Product: Eon Mini - 3788 (IPG), Eon Mini system is indicated as an aid in the management of chronic intractable pain of the trunk and/or limbs including unilateral or bilateral pain associated with the following: failed back, surgery syndrome, intractable low back and leg pain.. Reason: As part of St. Jude Medical's routine tracking and product monitoring, they have received a total of 214 reports, out of 34,617 Eon Mini IPGs, that lost the ability to communicate or recharge due to an inner battery weld issue resulting in loss of pain relief and subsequent explant. Explant surgery, as with any surgery, presents a risk to patient health. Adverse events associated with an unplanne.
- Recalling firm
- St. Jude Medical
- Classification
- Class II
- Status
- Terminated
- Initiated
- 2012-07-26
- Terminated
- 2015-08-21
- Firm location
- Plano, TX, United States
Product description
Eon Mini - 3788 (IPG), Eon Mini system is indicated as an aid in the management of chronic intractable pain of the trunk and/or limbs including unilateral or bilateral pain associated with the following: failed back, surgery syndrome, intractable low back and leg pain.
Reason for recall
As part of St. Jude Medical's routine tracking and product monitoring, they have received a total of 214 reports, out of 34,617 Eon Mini IPGs, that lost the ability to communicate or recharge due to an inner battery weld issue resulting in loss of pain relief and subsequent explant. Explant surgery, as with any surgery, presents a risk to patient health. Adverse events associated with an unplanne
Data sourced from openFDA. This site is unofficial and independent of the FDA.