The Medicines and Healthcare products Regulatory Agencies (MHRA), United Kingdom posted a field safety notice concerning the SynchroMed® II Pump, manufactured by Medtronics Inc.
The notice provided important information regarding the "Schedule to replace the pump by" date displayed on the Model 8840 N'Vision® physician programmer and printed reports, for the Model 8637 SynchroMedR II implantable drug infusion pump.
In some circumstances after a pump's Elective Replacement Indicator (ERI) has occurred, the "Schedule to replace the pump by" date may be incorrectly displayed as a series of question marks (??/??/????), or as a date greater than 90 days from the ERI date, potentially leading to the pump reaching End of Service (EOS) prior to replacement.
Medtronic has confirmed that an algorithm used in the Model 8870 application card software has resulted in nine occurrences of an incorrectly displayed "Schedule to replace the pump by" date. It is estimated that there are more than 140,000 SynchroMed II pump implants worldwide.
A patient with a pump reaching EOS prior to replacement may experience the return of underlying symptoms and/or withdrawal symptoms. Intrathecal baclofen patients could experience baclofen withdrawal syndrome, which can be life threatening.
No adverse events have been reported for eight of the confirmed cases, and one Intrathecal Baclofen Therapy (ITB) patient experienced decreased therapeutic effect with increased spasticity due to the pump reaching EOS prior to replacement.
The manufacturer advised customers to take the following actions:
For details, please refer to the following MHRA website:
http://www.mhra.gov.uk/Safetyinformation/Safetywarningsalertsandrecalls/fieldsafetynotices/index.htm
If you are in possession of the product, please contact your supplier for necessary actions.