Medtronic 483 Notes Issues With Nonconforming Product

Medtronic Neuromodulation received a Form 483 after it continued to distribute models of SC catheters that didn’t conform to an updated design, intended to fix a field issue. The older models “have attributed to 60 complaints of catheter occlusion since September 2012,” according to the April 3 form.

The Minneapolis-based company also distributed lead kits containing nonconforming lead caps between Nov. 19, 2012, and Jan. 20, the FDA found. The company’s procedure requires an approved product deviation to distribute nonconforming product; however, the company did not authorize a product deviation for the kits until Feb. 7.

A CAPA-related observation noted that Medtronic hadn’t implemented a corrective action to correct feed-through shorting that caused motor stalls in its SynchroMed II infusion pumps.

Meanwhile, health hazard assessments for high-priority CAPAs were not completed in a timely fashion and the company failed to perform testing to verify that a January 2011 design change did not adversely affect its DBS lead extensions and lead caps. Seventy-five of 103 complaints about connector block twisting and DBS lead damage had been received since February 2011.

Medtronic takes FDA feedback seriously and is making improvements to the Neuromodulation quality system in response to the observations, spokeswoman Donna Marquard said.

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