Safety Alert for MEDTRONIC INTERSTIM STIMULATOR ELECTRODE - Registration 10339190171 - Models 3093 - 3889 - Lots / Series: According to annex - Distribution List .. http://portal.anvisa.gov.br/wps/wcm/connect/1f2b3000454c272b836dd32475bf1155/distribuicao.pdf? MOD = AJPERES

Brazilian data is current through June 2018. All of the data comes from Anvisa, except for the categories Manufacturer Parent Company and Product Classification.
The Parent Company and the Product Classification were added by ICIJ.
The parent company information is based on 2017 public records. The device classification information comes from FDA’s Product Classification by Review Panel, based on matches of data from the U.S. and Brazil.

During August 2010, Medtronic received 45 (forty-five) reports involving the Model 3093 or 3889 - Interstim Stimulator Electrodes that ruptured during extraction and resulted in the retention of a fragment of the device in the patient's body . These 45 reports are part of an estimate of 4,482 electrodes extracted, totaling an occurrence rate of approximately 1%. Such an occurrence rate is based on voluntary and spontaneous reports and may be below the actual rate. Of these 45 reports, two reports were of residual pain and / or discomfort, one report of potential migration of the fragment and four reports of surgery for fragment extraction. The other reports did not include patient-specific outcome information. Anvisa is following this case.