SYNCHROMED II Programmable Infusion Pump - ANVISA Registration No. 10099430103. 의 안전성 경고

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.

Medtronic has confirmed that an algorithm used in the Model 8870 application card software resulted in nine (9) occurrences of an incorrect date display on the "Schedule to replace the pump by" display. It is estimated that there are more than 140,000 SynchroMed II pump implants worldwide. A patient with a pump that reaches EOS before replacement may feel the return of underlying symptoms and / or withdrawal symptoms of the drug. Patients with intrathecal baclofen may experience baclofen withdrawal, which may lead to life-threatening conditions. No adverse event was reported for eight (8) of the confirmed cases, and one patient on Intrathecal Baclofen Therapy (ITB) experienced a decrease in the therapeutic effect with increased spasticity due to the pump reaching EOS prior to replacement Recommendations: • Continue the follow-up program normal, and monitor the estimated number of months until ERI. This information can be found on the Pump Status screen, the Alarms screen, and the Print Reports Session (see Figure 2). "The" PTM® Model 8835 also indicates whether the pump has reached ERI (Pump Alarm Screen, code 8615). • Follow label recommendations for pump replacement within 90 days * from the ERI statement. To determine the ERI date, review the Pump Status screen and the Alarm screen * A minimum of 90 days at a rate of up to 1.5 mL / day, between ERI activation and EOS, according to the device label .