Medical device manufacturer, Boston Scientific, has issued a medical device safety alert concerning its Latitude Programmer [Model: 3300; Description: PRGMR LATITUDE US 3300].
Upon Limited Market Release to the US in May 2018, customer complaints were received regarding the 3300 Programmer integrated Pacing System Analyzer (PSA) when attempting to evaluate lead impedances. Complaints described that while pacing the RA lead, capture and pacing were also observed in the RV lead.
According to the manufacturer, the PIR team concludes that while the product is manufactured per specifications, the current cross chamber stimulation behaviour does not meet the intent of System Requirements. Therefore, the PSA Application reflects an increase risk to patients and a field removal is recommended to return 3300 Programmers to the manufacturer.
The 3300 is also in Limited Market Release in Europe. No other geographies are currently approved for the 3300-programmer use.
According to the local supplier, the affected products are not distributed in Hong Kong.
If you are in possession of the products, please contact your supplier for necessary actions.
Posted on 13 September 2018