MAUDE Adverse Event Report: MEDTRONIC NEUROMODULATION ENTERRA LEAD; INTESTINAL STIMULATOR

Model Number NEU_UNKNOWN_LEAD

Device Problems High impedance (1291); Device Difficult to Program or Calibrate (1496)

Patient Problems Nausea (1970); Vomiting (2144); Therapeutic Response, Decreased (2271)

Event Type  malfunction  

Manufacturer Narrative

(b)(4).

Event Description

The manufacturer representative reported there was an impedance measurement of 1168 ohms between electrodes 2 and 3.The patient was implanted two months prior and their symptoms were returning.They experienced symptoms of nausea and vomiting.The physician calculated a new voltage with 1168 ohms and 5 ma.However they could not program a new voltage with 7.5 ma.There was question of whether this was related to the high impedance.Regarding the cause of the high impedance, it was inquired if it was possibly due to inflammation around the lead, as they were recently implanted and if it could be temporary.In addition, it was wondered if a lead break should be considered even if the impedance was not greater than 4,000 ohms.No cause was determined.An x-ray was advised to check the position of the leads.In addition, further actions included increasing the current to 10 ma and watching the impedance measurement.No further information was provided.A follow up report will be sent if additional information is received.

• Brand Name: ENTERRA LEAD
• Type of Device: INTESTINAL STIMULATOR
• Manufacturer (Section D): MEDTRONIC NEUROMODULATION; 800 53rd ave ne; minneapolis MN 55421 1200
• Manufacturer (Section G): MEDTRONIC NEUROMODULATION; 7000 central avenue ne rcw215; minneapolis MN 55432
• Manufacturer Contact: diane wolf ; 7000 central avenue ne rcw215; minneapolis, MN 55432 ; 7635263987
• MDR Report Key: 5469317
• MDR Text Key: 39347577
• Report Number: 3007566237-2016-01099
• 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,foreig
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 02/11/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: NEU_UNKNOWN_LEAD
• Device Catalogue Number: NEU_UNKNOWN_LEAD
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 02/11/2016
• Initial Date FDA Received: 02/29/2016
• 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