MAUDE Adverse Event Report: MEDTRONIC NEUROMODULATION IMPLANTABLE NEUROSTIMULATOR; INTESTINAL STIMULATOR

Model Number NEU_ENTERRA_INS

Device Problem High impedance (1291)

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

Event Date 05/09/2017

Event Type  malfunction  

Manufacturer Narrative

The main component of the system and other applicable components are: product id: neu_unknown_lead, product type: lead.

Event Description

The manufacturer representative (rep) reported that the healthcare provider (hcp) was in surgery on the day of the report to replace the implantable neurostimulator (ins).The hcp told the rep that the impedance was over 800 ohms, but it was not greater than 4,000 ohms.It was also indicated that the hcp wanted to know if the ins could be activated, and that they may go back in at a later date to revise the lead.The rep mentioned that the hcp made sure the connections were wiped off and secure.There were no symptoms or complications reported as a result of this event.

• Brand Name: IMPLANTABLE NEUROSTIMULATOR
• Type of Device: INTESTINAL STIMULATOR
• 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: 6661485
• MDR Text Key: 78255919
• Report Number: 3007566237-2017-02493
• Device Sequence Number: 1
• Product Code: LNQ
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: H990014
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 06/22/2017

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_ENTERRA_INS
• Device Catalogue Number: NEU_ENTERRA_INS
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 05/09/2017
• Initial Date FDA Received: 06/22/2017
• 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