MAUDE Adverse Event Report: MEDTRONIC MED REL MEDTRONIC PUERTO RICO ENTERRA; INTESTINAL STIMULATOR

Model Number 3116

Device Problems Failure to Deliver Energy (1211); Electromagnetic Compatibility Problem (2927)

Patient Problems Therapeutic Effects, Unexpected (2099); Vomiting (2144); Complaint, Ill-Defined (2331)

Event Type  malfunction  

Event Description

It was later indicated that a programmer was shipped out.The patient was helped over the phone on interrogating the device by the company representative.The device was found to be on however settings were not correct.It was stated that it was like it returned to factory settings and were not high enough to provide effect.The health care provider increased settings and patient returned to baseline of therapy coverage they had before the surgery on tonsils.The patient was currently receiving effective therapeutic benefit.The health care provider did indicate that his office sent back the programmer that was sent out to them.

Manufacturer Narrative

(b)(4).

Event Description

It was reported that the patient was an inpatient at a hospital.The patient experienced a loss of therapeutic effect.It was noted that it worked great until the implant was turned off to do a tonsil surgery.Apparently, the device was turned back on after the procedure; however, the patient never regained therapeutic benefit.The patient had been throwing up ever since.The patient was currently not feeling stimulation; it was unknown if they ever felt stimulation.The loss of therapeutic benefit had been since september 2014.Since then the patient had been having issues.No interventions or outcome were reported regarding this event.Further follow-up is being conducted to obtain this information.If additional information is received, a follow-up report will be sent.

Manufacturer Narrative

Concomitant medical product: product id 4351-35, serial# (b)(4), implanted: (b)(6) 2013, product type: lead; product id 4351-35, serial# (b)(4), implanted: (b)(6) 2013, product type: lead.(b)(4).

• Brand Name: ENTERRA
• Type of Device: INTESTINAL STIMULATOR
• Manufacturer (Section D): MEDTRONIC MED REL MEDTRONIC PUERTO RICO; ceiba norte industrial park, r; 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: 4370001
• MDR Text Key: 17693033
• Report Number: 3004209178-2014-24654
• 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
• Report Date: 12/05/2014

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: 07/14/2014
• Device Model Number: 3116
• Device Catalogue Number: 3116
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 01/13/2015
• Initial Date FDA Received: 12/30/2014
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 01/22/2015
• Date Device Manufactured: 01/14/2013
• 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: 00039 YR