MAUDE Adverse Event Report: MEDTRONIC PUERTO RICO OPERATIONS CO. ENTERRA; INTESTINAL STIMULATOR

Model Number 3116

Device Problems Electromagnetic Interference (1194); Failure to Deliver Energy (1211); High impedance (1291); Unintended Collision (1429); Inappropriate/Inadequate Shock/Stimulation (1574); Device Operates Differently Than Expected (2913)

Patient Problems Nausea (1970); Therapeutic Response, Decreased (2271); Electric Shock (2554)

Event Date 01/14/2015

Event Type  malfunction  

Event Description

Additional information received reported the patient received assistance from their doctor or manufacturer representative on (b)(4) 2015 and their concerns were resolved.The setting on the device was increased.No further information was reported.

Event Description

It was reported that a patient¿s device completely took her nausea and vomiting away within 24 hours of implant surgery.On (b)(6) 2015, she was involved in a car accident and was rear-ended.The patient had multiple x-rays and two ct scans.Since the accident, it was like her device had just quit.Her nausea had returned and it felt like it had been ¿turned off or something.¿ the patient also experienced a jolting or shocking sensation several different times.She didn¿t understand why it would stop working and it worried her because it happened at the time of the wreck and being in the emergency room.The patient wanted to know if ct scans would affect the device.She planned to go to her doctor to have it checked.It was later reported that there had been 50 percent or greater symptom reduction, troubleshooting included interrogation, and there was no evidence that the device was damaged.The event cause was not determined and was not device related.Electrode impedances for all pairs with electrodes 0 and 1 were greater than 4000 ohms.The patient was programmed on 2 negative, 3 positive and had a therapy impedance measurement of 608 ohms.The patient saw her healthcare provider on (b)(6 )2015 and was complaining of nausea.No outcome was reported regarding this event.Further follow-up is being conducted to obtain additional information.If additional information is received, a follow-up report will be sent.

Manufacturer Narrative

Concomitant medical products: product id: 4351-35, serial# (b)(4), implanted: (b)(6) 2014, product type: lead.Product id: 4351-35, serial# (b)(4), implanted: (b)(6) 2014, product type: lead.(b)(4).

• Brand Name: ENTERRA
• Type of Device: INTESTINAL STIMULATOR
• Manufacturer (Section D): MEDTRONIC PUERTO RICO OPERATIONS CO.; road 31, km. 24, hm 4; ceiba norte industrial park; juncos PR 00777
• 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: 4609273
• MDR Text Key: 5651703
• Report Number: 3004209178-2015-04834
• 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: Consumer,Health Professional
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 02/23/2015

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 Expiration Date: 10/28/2015
• Device Model Number: 3116
• Device Catalogue Number: 3116
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 03/31/2015
• Initial Date FDA Received: 03/17/2015
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 04/15/2015
• Date Device Manufactured: 05/01/2014
• 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: 00044 YR