| | Class 1 Device Recall Infinity 5 IPG |  |
| Date Initiated by Firm | July 18, 2023 |
|---|
| Date Posted | September 11, 2023 |
|---|
| Recall Status1 |
Open3, Classified |
| Recall Number | Z-2510-2023 |
|---|
| Recall Event ID |
92688 |
| PMA Number | P010032 P010032S096 P010032S151 |
|---|
| Product Classification |
Stimulator, spinal-cord, totally implanted for pain relief - Product Code LGW
|
| Product | Infinity 5 Implantable Pulse Generator REF 6660
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 deliver stimulation with a single program or with multiple programs. Each program can provide stimulation to a single anatomical area or to multiple areas. The IPG communicates wirelessly with system programmers and controllers, and the IPGs are available in small and large sizes to accommodate different power needs.
The Proclaim" XR and Proclaim" Plus IPGs are used for Spinal Cord Stimulation (SCS). The Proclaim" DRG IPG is used for Dorsal Root Ganglion (DRG) stimulation. The Infinity" IPG is used for Deep Brain Stimulation (DBS). |
|---|
| Code Information |
Model Number: 6660
UDI-DI Codes:
05415067030016
Serial Numbers:
US
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CFU599.1
CFU637.1
CFV512.1
CFV536.1
CFV571.1
CFV705.1
CFV795.1
CFV808.1
CFX138.1
CFX140.1
CFX179.1
CFX201.1
CFX214.1
CFX301.1
CFX401.1
CFZ937.1
CGA006.1
CGA019.1
CGA022.1
CGA122.1
CGA227.1
CGA239.1
CGA343.1
CGA530.1
CGA543.1
CGD806.1
CGD820.1
CGG926.1
CGG939.1
CGH092.1
CGH118.1
CGH313.1
CGH430.1
CGH779.1
CGH785.1
CGH811.1
CGH885.1
CGL026.1
CGL064.1
CGL099.1
CGL263.1
CGL298.1
CGL299.1
CGL341.1
CGL365.1
CGL411.1
CGL427.1
CGL729.1
CGL745.1
CGL761.1
CGL762.1
CGL767.1
CGL771.1
CGL773.1
CGL802.1
CGL813.1
CGP070.1
CGP074.1
CGP115.1
CGP183.1
CGP204.1
CGP211.1
CGP262.1
CGP286.1
CGP303.1
CGP448.1
CGS702.1
CGS704.1
CGS744.1
CGS789.1
CGS806.1
CGS813.1
CGS821.1
CGS848.1
CGS850.1
CGU053.1
CGU059.1
CGU085.1
CGU092.1
CGU129.1
CGU142.1
CGU240.1
CGU252.1
CGU297.1
CGU302.1
CGU303.1
CGW270.1
CGY885.1
CHB090.1
CHB130.1
CHB184.1
CHB228.1
CHE807.1
CHE852.1
CHE859.1
CHF028.1
CHF051.1
CHF189.1
CHH652.1
CHH748.1
CHH796.1
CHH798.1
CHH808.1
CHH834.1
CHH845.1
CHH873.1
CHK299.1
CHK381.1
CHK492.1
CHK574.1
CHK579.1
CHK636.1
CHK662.1
CHL944.1
CHL953.1
CHM024.1
CHM052.1
CHM123.1
CHM201.1
CHM235.1
CHM270.1
CHM350.1
CHM402.1
CHM429.1
CHM463.1
CHM495.1
CHM546.1
CHM569.1
CHM591.1
CHP624.1
CHP729.1
CHR146.1
CHR202.1
CHT294.1
CHT322.1
CHT466.1
CHT533.1
CHT534.1
CHT537.1
CHT687.1
CHT833.1
CHV708.1
CHV746.1
CHW477.1
CHW483.1
CHW520.1
CHW558.1
CHZ470.1
YW0022.1
YW0038.1
YW0089.1
YW0185.1
YW0238.1
YW0282.1
YW0387.1
YW0483.1
YX8973.1
YX8974.1
YX9006.1
YX9010.1
YX9012.1
YX9026.1
YX9031.1
YX9048.1
YX9058.1
YX9063.1
YX9149.1
YY3001.1
YY3014.1
YY6058.1
YZ1455.1
YZ1474.1
YZ1543.1
YZ1550.1
YZ1556.1
YZ1613.1
YZ9626.1
YZ9694.1
YZ9704.1
YZ9730.1
YZ9748.1
YZ9758.1
YZ9771.1
YZ9780.1
YZ9817.1
YZ9897.1
YZ9902.1
ZY8841.1
ZY9281.1
ZY9324.1
ZY9483.1 |
Recalling Firm/
Manufacturer |
Abbott Medical
6901 Preston Rd
Plano TX 75024-2508
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| For Additional Information Contact | Carolina Castano
512-286-4021 |
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Manufacturer Reason
for Recall | Firm has received complaints from patients who are unable to exit MRI (Magnetic Resonance Imaging) mode on their IPGs (Implantable Pulse Generators). |
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FDA Determined
Cause 2 | Under Investigation by firm |
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| 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, patients are advised to contact their physician before having an MRI to discuss all critical information regarding MRI scans and MRI mode. In alignment with the Clinician Programmer and Patient Controller Instructions for Use, Abbott recommends physicians do the following:
"
For the Patient Controller, advise the patient not to delete the paired Bluetooth connection between their IPG and the Patient Controller and not to alter, damage or lose their Patient Controller while the IPG is in MRI mode.
"
For the Patient Controller prior to entering MRI mode, ensure patients have upgraded their Patient Controller to the latest "Patient Controller NR - US" application from the Apple! App Store!. This version of the application provides instructions for the user not to delete the IPG pairing while the system is in MRI mode.
"
For the Clinician Programmer, maintain the paired Bluetooth connection between the IPG and the Clinician Programmer by avoiding deleting the pairing and disabling automatic iOS! software upgrades from the iOS! settings.
"
For questions about this issue or to report patients who are unable to exit MRI mode, please contact your local Abbott representative or Abbott Technical Support at 1-800-727-7846 (option 3) for assistance. |
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| Quantity in Commerce | 5,932 devices (US-4,464; OUS-1,468) |
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| 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 countries of Algeria, Argentina, Australia, Austria, Belgium, Brazil, Canada, Chile, Colombia, Costa Rica, Czech Republic, Denmark, Ecuador, Estonia, Finland, France, Germany, Greece, Hungary, India, Iraq, Ireland, Israel, Italy, Japan, Korean, Kuwait, Lithuania, Luxembourg, Mexico, Netherlands, New Zealand, Norway, Pakistan, Poland, Portugal, Reunion, Russian Federation, Saudi Arabia, Singapore, Slovenia, South Africa, Spain, Sweden, Switzerland, Taiwan, Turkey, United Arab Emirates, United Kingdom. |
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| Total Product Life Cycle | TPLC Device Report |
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1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 The manufacturer has initiated the recall and not all products have been corrected or removed. This record will be updated as the status changes.
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| PMA Database | PMAs with Product Code = LGW
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