MAUDE Adverse Event Report: MEDTRONIC NEUROMODULATION ENTERRA; INTESTINAL STIMULATOR

Model Number 37800

Device Problems High impedance (1291); Device Contamination with Chemical or Other Material (2944)

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

Event Date 01/11/2017

Event Type  malfunction  

Manufacturer Narrative

Other applicable components are: product id: neu_unknown_lead, lot# unknown, product type: lead.

Event Description

A healthcare professional (hcp) reported currently in or replacing an implantable neurostimulator (ins).The consumer was getting good therapy, with no falls reported.An initial impedance taken with the ins outside the pocket was c2: >2k ohms, c3: >2k ohms, and 23: >2k ohms.The hcp reported he had taken out the lead and wiped it down.Troubleshooting requested removing the lead and wiping it again; the hcp reported he did see some ¿dirt¿ when the lead was removed and physician indicated he wiped it down again.Re-inserting the lead, electrode impedance tested at 3v was as follows: c2: 416 ohms, c3: 436 ohms, and 23: 757 ohms.The hcp programmed nominal settings and the issue resolved.No symptoms were reported.

Manufacturer Narrative

If information is provided in the future, a supplemental report will be issued.

• Brand Name: ENTERRA
• 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 clark ; 7000 central avenue ne rcw215; minneapolis, MN 55432 ; 7635263920
• MDR Report Key: 6257828
• MDR Text Key: 65038454
• Report Number: 3007566237-2017-00162
• 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: health professional
• Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date: 01/17/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/17/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 37800
• Device Catalogue Number: 37800
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 01/11/2017
• 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
• Patient Age: 36 YR