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); Vomiting (2144); Therapeutic Response, Decreased (2271); Malaise (2359); Abdominal Distention (2601); Constipation (3274)

Event Type  Injury  

Event Description

It was reported that the patient¿s hcp (healthcare provider) wants some technical specs regarding device.There were differences between her obstetrician doctor and her gastrointestinal doctor in thoughts regarding use of gastric pacemaker.The patent reports no stimulation sensation because hcp made a decision to turn off at time when the patient was attempting to get pregnant and now that she was pregnant he will not turn on.The plan was to keep it off just for the first trimester and turn it back on.Hcp originally turned off device in (b)(6) 2012.She got really sick so it was turned back on (b)(6) 2012 and she states it was turned off again beginning of (b)(6) 2012.The patient was (b)(6) pregnant.The symptoms were reported as nausea, vomiting, stomach was bloated out like she was 9 months pregnant, it goes down then it goes back up, fatigue, constipation.Hcp was monitoring her albumin level for nutrition, fatigue and emotional aspect while she was pregnant.Some of these symptoms may be due to her pregnancy.They were watching her constipation to make sure she doesn¿t get a small bowel obstruction and states she was now back to drinking liquids like prior to implant.It was later reported that the healthcare provider discovered that the patient was pregnant and the device was turned off (b)(6) 2012.No abnormal impedance reported.The patient had increased nausea and vomiting which coincident with pregnancy.No injury was reported.Additional information received reports patient had a loss of therapeutic effect.The setting were not helping her symptoms of nausea.She was told by the hcp(healthcare provider) that "it wasn't connecting right" but states she wasn't exactly sure what that meant.The device did help for a while but then turned the stimulation off because she had a baby in 2012.After she had the baby she turned the stimulation back on.About 3 months after it wasn't working right.They knew it wasn't working right either because she was needing to have weekly iron infusions and hemoglobin had dropped and needed weekly blood transfusions.She ended up having it replaced in (b)(6) 2014 because of this issue.

Manufacturer Narrative

Concomitant products: product id 435135, serial # (b)(4), implanted: (b)(6) 2010, product type lead; product id 435135, serial # (b)(4), implanted: (b)(6) 2010, product type lead.(b)(4).

Manufacturer Narrative

(b)(4).The patient reports becoming pregnant while implanted with and utilizing enterra therapy.Upon becoming pregnant, her hcp discontinued therapy which resulted in a return of gastroparesis symptoms including nausea, vomiting and bloating.These events are assessed as not likely related to enterra therapy but instead likely related to her underlying diagnosis of gastroparesis and/or her pregnancy.

• 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: 4672223
• MDR Text Key: 5621461
• Report Number: 3004209178-2015-06228
• 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: 04/06/2015

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: 12/28/2011
• 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: 06/23/2015
• Initial Date FDA Received: 04/09/2015
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 06/26/2015
• Date Device Manufactured: 07/08/2010
• 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): Required Intervention
• Patient Age: 00034 YR