MAUDE Adverse Event Report: MEDTRONIC NEUROMODULATION IMPLANTABLE NEUROSTIMULATOR; STIMULATOR, ELECTRICAL, IMPLANTABLE, FOR INCONTINENCE

Model Number NEU_INS_STIMULATOR

Device Problems High impedance (1291); Unable to Obtain Readings (1516)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 07/19/2017

Event Type  malfunction  

Manufacturer Narrative

Concomitant products: product id: neu_unknown_lead, implanted: (b)(6) 2017, product type: lead.A good faith effort will be made to obtain the applicable information relevant to the report.If information is provided in the future, a supplemental report will be issued.

Event Description

Information was received from a manufacturer representative regarding a patient implanted with an implantable neurostimulator.It was reported that the patient was having a revision, so they placed a brand new lead with a new ins and was showing high impedance.It was noted that they had already turned off the lights, moved out of the field, dried off ins/sensors, and increased amplitude when testing from 1.0 to 1.5 to 2.0v and everything looked fine.They hooked up the old ins to the lead and were getting the same results, which approximately 5 combinations were over 4000 ohms and the rest were around 1300-2300 ohms.It was mentioned they saw the blue tip, heard screw torque down and did not see that it was loose at all.Patient was larger so they were pushing down on the pocket to make sure everything was making a connection.Combinations over 4000 ohms were 0-1, 0-2, 0-3, 1-2, 1-3 and other values range from 1100-2300 ohms.Impedances were ran on the old ins at 2.0v, 360 pulse width which showed ??? on c-3 and combinations of 0-1, 0-2, 1-2 were over 4000 with other combinations being around 3800 ohms and then 8840 noted measurement could not be taken at these settings.The physician retested and got similar impedance results.The new ins was reconnected to the lead and it was confirmed connections were secure and the lead was not moving at all in the header block.A new program was set up with the new ins to check bellows response and on 0-1 they saw bellows at 2.7v and on 0-2 they saw bellows at 2.4v.It was reviewed that while impedances were high, the circuit appeared to be completed and the current was getting through the system.It was further reviewed that even with the way impedances were measured and the fact they were high, if they were seeing bellows response they should be able to use those electrodes in programmer post-operatively.No further complications were reported.

• Brand Name: IMPLANTABLE NEUROSTIMULATOR
• Type of Device: STIMULATOR, ELECTRICAL, IMPLANTABLE, FOR INCONTINENCE
• Manufacturer (Section D): MEDTRONIC NEUROMODULATION; 800 53rd ave ne; minneapolis MN 55421 1200
• Manufacturer (Section G): MEDTRONIC NEUROMODULATION; 800 53rd ave ne; minneapolis MN 55421 1200
• Manufacturer Contact: lisa woodward clark ; 7000 central avenue ne rcw215; minneapolis, MN 55432 ; 7635263920
• MDR Report Key: 6734315
• MDR Text Key: 80869154
• Report Number: 3007566237-2017-02986
• Device Sequence Number: 1
• Product Code: EZW
• Combination Product (y/n): N
• PMA/PMN Number: P970004
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 07/21/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: NEU_INS_STIMULATOR
• Device Catalogue Number: NEU_INS_STIMULATOR
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 07/19/2017
• Initial Date FDA Received: 07/21/2017
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1