Examining the Need to Standardize Implanted Stimulator Connectors: NANS Survey Results

Connectors between implanted stimulator electrodes and pulse generators allow revisions, including battery changes or generator upgrades, to proceed without disturbing uninvolved components, such as the electrode. As new devices are introduced, however, connector incompatibility, even with updated hardware from the same manufacturer, can lead to additional procedures, expense, and morbidity.

Following the example of the cardiac pacemaker/defibrillator industry, the Institute of Neuromodulation (IoN) met to explore the possibility of creating connector standards for implanted neurostimulation devices. At a subsequent meeting of the Association for the Advancement of Medical Instrumentation, which coordinates the development of such standards, industry representatives asked for data defining the need for a new standard. Accordingly, IoN prepared an online survey to be sent to the North American Neuromodulation Society mailing list regarding experience with the connectivity of spinal cord stimulation (SCS) generators and electrodes.

The 87 respondents of 9657 surveyed included 77 clinicians, who reported a total of 42,572 SCS implants and revisions. More than a quarter of revisions (2741 of 9935) required the interconnection of devices made by separate manufacturers, in most cases (n = 1528) to take advantage of a new feature (e.g., rechargeability, new waveform) or because an original component could not be replaced (n = 642). Connector adapters provided by manufacturers were used in less than half (n = 1246) of these cases. Nearly all (94%) of the clinicians agreed that standardized connectors should be developed for SCS, and 86% opined that standardized connectors should be developed for other neurostimulation therapies.

Those who responded to our survey support the development of standard connectors for implanted stimulators, with voluntary compliance by manufacturers, to mitigate the need for adapters and facilitate interchanging components when appropriate. Other advantages to patients and manufacturers might accrue from the adoption of standards, as technology evolves and diversifies.