MD+DI Online is part of the Informa Markets Division of Informa PLC

This site is operated by a business or businesses owned by Informa PLC and all copyright resides with them. Informa PLC's registered office is 5 Howick Place, London SW1P 1WG. Registered in England and Wales. Number 8860726.

Medtronic Recalls SynchroMed II Implantable Drug Infusion Pump

Medtronic Recalls SynchroMed II Implantable Drug Infusion Pump

The company has confirmed five reports of motor stall due to the presence of a foreign particle, which resulted in drug withdrawal, surgery to replace the pump, and delay of care.

There have been 45 medical device recalls issued in 2019 according to FDA, compared to just 32 medical device recalls in each of the previous two years. See the chart below for a breakdown of 2016-2019 medical device recalls by month.

Most recently, FDA reported that Medtronic has recalled its SynchroMed II implantable drug infusion pump, part of the SynchroMed Infusion System, after receiving reports of early motor stall due to the potential presence of foreign particles inside the pump motor assembly. The pump is used together with a catheter to deliver a specific drug to the patient's spinal fluid.

The company confirmed five reports of motor stall due to the presence of a foreign particle, which resulted in drug withdrawal, surgery to replace the pump, and delay of care. A sixth pump, which was removed surgically due to an unrelated infection, was later found to contain a foreign particle, but there was no indication of a motor stall. No deaths have been reported in connection to this issue.

TAGS: News
Hide comments
account-default-image

Comments

  • Allowed HTML tags: <em> <strong> <blockquote> <br> <p>

Plain text

  • No HTML tags allowed.
  • Web page addresses and e-mail addresses turn into links automatically.
  • Lines and paragraphs break automatically.
Publish