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

Model Number 37800

Device Problems High impedance (1291); Unintended Collision (1429); Device Contamination with Chemical or Other Material (2944)

Patient Problems Nausea (1970); Seroma (2069); Therapeutic Effects, Unexpected (2099); Vomiting (2144); Therapeutic Response, Decreased (2271)

Event Date 04/11/2016

Event Type  Injury  

Event Description

Patient did very well for about a month then her symptoms of nausea and vomiting returned.During the return of her symptoms she had an episode where she fell (sometime in (b)(6)).She went into doctor's office a day prior to this call and while doing a programming check they found her impedance was out of range.C and 2 was 12,000, c and 3 was around 300, and 2 and 3 was 6,000.They are going to take her to the operation room (or) on (b)(6) to see if they can find the issue.It was noted that surgical intervention was planned and has been scheduled on (b)(6).The reported issue was not resolved at the time of this report.The indications for use for this patient were gastric stimulation and gastrointestinal/pelvic floor.

Event Description

Additional information received from the manufacturer representative reported that the hcp opened the pocket on (b)(6) 2016 and found a lot of fluid in the pocket.Once the hcp unscrewed the setscrews, there was some fluid in the header block.The hcp cleaned it out and retightened the screws and the impedance was at 460 ohms.

Event Description

Additional information from the manufacturing representative (rep) reported the patient has not done well with their nausea and vomiting symptoms since they had the problem with the lead.The hcp may do a pyloroplasty on the patient, but nothing was set as of the report.

Manufacturer Narrative

If information is provided in the future, a supplemental report will be issued.

• 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 PUERTO RICO OPERATIONS CO.; road 31, km. 24, hm 4; ceiba norte industrial park; juncos PR 00777
• Manufacturer Contact: lisa clark ; 7000 central avenue ne rcw215; minneapolis, MN 55432 ; 7635263920
• MDR Report Key: 5707884
• MDR Text Key: 46852820
• Report Number: 3004209178-2016-11168
• 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,health
• Reporter Occupation: Health Professional
• Type of Report: Initial,Followup,Followup,Followup
• Report Date: 01/24/2017

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: 03/14/2017
• Device Model Number: 37800
• Device Catalogue Number: 37800
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 05/12/2016
• Initial Date FDA Received: 06/08/2016
• Supplement Dates Manufacturer Received: Not provided; Not provided; 01/18/2017
• Supplement Dates FDA Received: 07/07/2016; 01/24/2017; 09/22/2017
• Date Device Manufactured: 09/23/2015
• 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: 44 YR