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U.S. Department of Health and Human Services

Class 2 Device Recall Precision Implantable Pulse Generators

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  Class 2 Device Recall Precision Implantable Pulse Generators see related information
Date Initiated by Firm October 05, 2007
Date Posted February 27, 2008
Recall Status1 Terminated 3 on February 29, 2012
Recall Number Z-0961-2008
Recall Event ID 45853
Product Classification Implanted spinal-cord stimulator for pain relief - Product Code LGW
Product Advanced Bionics Precision Implantable Pulse Generator Kit, Model Number SC-1100 with firmware version prior to Revision 3.02, Advanced Bionics Corportation, Sylmar, CA 91342
Code Information Serial Numbers:  367 379 408 418 429 432 435 436 438 462 467 473 490 601 608 625 636 655 660 661 666 667 671 679 681 683 685 691 696 712 715 719 724 731 732 734 744 745 748 770 1011 1012 1015 1016 1017 1022 1024 1027 1030 1035 1038 1044 1046 1048 1051 1053 1056 1065 1066 1068 1076 1077 1079 1083 1085 1090 1091 1093 1094 1095 1096 1102 1103 1105 1108 1111 1115 1117 1121 1129 1131 1141 1142 1146 1149 1153 1154 1158 1159 1161 1164 1167 1168 1169 1170 1171 1177 1179 1180 1185 1186 1188 1190 1191 1213 1214 1218 1219 1220 1221 1222 1224 1225 1226 1231 1232 1233 1237 1238 1240 1241 1242 1245 1246 1257 1266 1267 1269 1272 1273 1274 1277 1280 1283 1285 1286 1401 1403 1404 1406 1408 1409 1412 1413 1414 1416 1420 1421 1426 1428 1429 1431 1432 1435 1437 1443 1444 1445 1446 1447 1448 1451 1458 1459 1464 1500 1502 1503 1508 1509 1511 1512 1513 1517 1519 1522 1526 1527 1528 1529 1530 1532 1535 1536 1541 1545 1550 1552 1554 1556 1558 1561 1563 1565 1566 1567 1568 1575 1578 1582 1583 1586 1587 1589 1593 1595 1596 1602 1605 1606 1608 1612 1613 1617 1620 1621 1622 1627 1630 1633 1634 1635 1637 1638 1639 1643 1645 1646 1647 1649 1650 1653 1654 1656 1659 1660 1661 1662 1665 1669 1670 1673 1682 1685 1686 1693 1696 1697 1698 1699 1706 1710 1711 1712 1713 1714 1715 1716 1718 1723 1731 1733 1739 1743 1744 1745 1746 1748 1749 1753 1756 1757 1758 1759 1763 1765 1767 1768 1769 1771 1774 1777 1779 1782 1783 1785 1786 1790 1791 1792 1794 1795 1796 1801 1806 1807 1808 1811 1812 1818 1819 1822 1825 1828 1831 1835 1836 1838 1839 1844 1845 1853 1855 1869 1871 1874 1878 1886 1893 1894 1896 1898 1899 2001 2003 2004 2005 2007 2011 2013 2015 2016 2018 2022 2024 2025 2027 2028 2031 2033 2034 2037 2040 2041 2042 2044 2046 2048 2054 2056 2057 2058 2061 2065 2066 2067 2070 2071 2072 2073 2075 2081 2083 2092 2094 2098 2102 2109 2111 2119 2124 2127 2132 2134 2138 2142 2150 2153 2158 2160 2163 2167 2168 2177 2178 2180 2182 2185 2191 2192 2199 2209 2212 2215 2221 2224 2238 2241 2242 2243 2246 2249 2251 2252 2257 2260 2262 2265 2268 2271 2275 2277 2278 2279 2283 2284 2285 2289 2291 2294 2295 2296 2299 2301 2305 2307 2311 2314 2317 2321 2328 2329 2334 2344 2346 2348 2352 2353 2363 2367 2368 2372 2376 2377 2378 2379 2380 2382 2387 2390 2391 2394 2397 2398 2401 2402 2403 2406 2408 2411 2412 2413 2418 2419 2425 2427 2430 2433 2437 2439 2441 2443 2445 2449 2452 2455 2457 2459 2460 2461 2466 2470 2473 2474 2475 2476 2488 2489 2496 2497 2498 2501 2502 2508 2513 2519 2521 2522 2523 2529 2531 2532 2545 2547 2548 2550 2556 2559 2562 2566 2575 2577 2582 2588 2591 2594 2596 2602 2603 2604 2610 2611 2619 2621 2630 2631 2632 2633 2637 2640 2646 2647 2648 2661 2665 2680 2681 2682 2684 2689 2694 2695 2698 2699 2706 2718 2723 2725 2726 2727 2728 2737 2739 2745 2746 2749 2752 2753 2766 2768 2777 2785 2805 2815 2819 2826 2827 2828 2840 2843 2844 2845 2848 2853 2854 2855 2857 2859 4156 4167 4172  
Recalling Firm/
Manufacturer		 Advanced Bionics Corp
12740 San Fernando Rd
Sylmar CA 91342-3728
For Additional Information Contact Kaoru Lee Adair
661-362-1669
Manufacturer Reason
for Recall		 Incorrect Data -- Corruption of internal memory component results in an inability for the physician to reprogram the IPG with firmware version prior to Revision 3.02. When this occurs, the IPG will report an error code of "10h0" or "00h0" through the Remote Control. Under this condition, the IPG will cease to log in some data that could be used for informational purposes. ** It should be noted t
FDA Determined
Cause 2		 Device Design
Action Advanced Bionics sent an Important Notification letter on October 5, 2007, via FED-Ex or US Postal Service Certified mail. (International notification activity is in progress.) The recall letter advises that the firm has become aware of an issue with Precision Implantable Pulse Generators (IPG model numbers SC-1100, Sc1110, and ONS-1110) manufactured prior to July 2007. The letter describes the issue in detail. The firm is requesting that customer immediately locate the affected IPGs and set them aside so that they are not used. A Boston Scientific/Advanced Bionics sales representative will contact your facility to confirm these IPGs and arrange for the exchange of these devices. The firm enclosed Reply Verification Tracking Form listing the IPGs that are at your Clinic according to the firm's records. In addition, the firm recommends that if error code 10h0 or 00h0 is encountered in Implanted IPGs, it may be corrected by upgrading to a newer version of IPG firmware (software that runs in the IPG). The new version of firmware corrects this condition and helps prevent it from occurring in the future. This firmware upgrade is performed non-invasively, through wireless RF telemetry. If any of patients encounter error code "10h0" or "00h0" on their Remote Control, consignees are advised to contact their Advanced Bionics representative or Technical Services team at (866) 566-8913 to help identify whether the condition can be corrected through a firmware upgrade and, if so, they will help arrange for the upgrade. Please note that some devices may not be upgradeable. The firm request that all consignees return the notification acknowledgement form is included with the letter.
Quantity in Commerce Over 12,000 units
Distribution Class II Recall - Worldwide Distribution --- including USA and countries of EU, Canada, Australia and Israel.
Total Product Life Cycle TPLC Device Report
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 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
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