Recall Z-2508-2023 ยท LGW Stimulator, Spinal-Cord, Totally Implanted For Pain Relief
Abbott Medical
Proclaim Plus 7 Implantable Pulse Generator REF 3672 Product Description: The implantable pulse generator (IPG) is an electronic device designed to be connected to one or more extensions or leads with up to 16 electrodes total. It is powered by a hermetically sealed battery within a titanium case and uses microelectronic circuitry to generate constant-current electrical stimulation. The IPG can d
| Date | Sep 11, 2023 (initiated Jul 18, 2023) |
| Status | Open, Classified |
| Reason | Firm has received complaints from patients who are unable to exit MRI (Magnetic Resonance Imaging) mode on their IPGs (Implantable Pulse Generators). |
| Root cause | Under Investigation by firm |
| Action | On 07/20/2023, the firm will send an "URGENT MEDICAL DEVICE CORRECTION" Letter via mail with delivery tracking to customers informing them, Abbott has received complaints from patients who are unable to exit MRI mode, as their Patient Controller has lost the ability to connect or communicate with their IPG while in MRI mode. Situations where this has occurred include where the user deleted the Bluetooth pairing, lost or disabled their Patient Controller, or upgraded the iOS! software on their Patient Controller while in MRI mode. Next Steps for Customers: Per Abbott's Instructions for Use, pa |
| Quantity | 387 devices (US only) |
| Distribution | Worldwide - US Nationwide distribution including in the states of AK, AL, AR, AZ, CA, CO, CT, DC, DE, FL, GA, HI, IA, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, MT, NC, ND, NE, NH, NJ, NM, NV, NY, OH, OK, OK, OR, PA, Puerto Rico, RI, SC, SD, TN, TX, UT, VA, VT, WA, WI, WV, and WY. The count |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.