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

Model Number 3116

Device Problems Failure to Deliver Energy (1211); Device Operates Differently Than Expected (2913)

Patient Problems Therapeutic Effects, Unexpected (2099); Malaise (2359)

Event Type  Injury  

Event Description

Additional information received reported that the patient still had concerns regarding their device or therapy but worked with their health care professional or manufacturer representative on 2015 (b)(6).The patient was still having concerns with their device and had not sought further help.

Event Description

(b)(4): the patient reported she was sick all the time, and could not feel it working at all.It was indicated that it stopped working about a month ago.The patient has been in the hospital since three days prior to this call.The patient status was reported as unknown.No outcome was reported regarding this event.A further follow-up is being conducted to obtain this information.A follow-up report will be sent if additional information becomes available.

Manufacturer Narrative

Concomitant product: product id 435135, serial # (b)(4), implanted: (b)(6) 2006, product type lead; product id 435135, serial # (b)(4), implanted: (b)(6) 2006, product type lead.(b)(4).

Event Description

Additional information indicated that patient had been really sick with symptoms of vomiting.About 2 weeks later it was reported that the intervention that was taken to resolve the loss of effect/return of symptom /device not working was that the device was tested in the office with the help of representative via phone and was working properly.

Manufacturer Narrative

(b)(4).

Event Description

Additional information indicated that patient had been really sick with symptoms of vomiting.About 2 weeks later, it was reported that the device was working properly when the device was tested in the office with the help of representative via phone.

• 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: 4887985
• MDR Text Key: 6033007
• Report Number: 3004209178-2015-12667
• 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,consumer,health profession
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 06/10/2015

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: 09/14/2007
• 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: 06/29/2015
• Initial Date FDA Received: 07/02/2015
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 07/13/2015
• Date Device Manufactured: 03/27/2006
• 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 Outcome(s): Hospitalization
• Patient Age: 00067 YR