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

Model Number 3116

Device Problems Migration or Expulsion of Device (1395); Unstable (1667); Device Operates Differently Than Expected (2913); Electromagnetic Compatibility Problem (2927)

Patient Problems Stroke/CVA (1770); Myocardial Infarction (1969)

Event Date 06/01/2014

Event Type  Injury  

Event Description

It was reported that the patient believes in (b)(6) 2014 their ins (stimulator) went dead.The patient went in mid-august to get the ins (stimulator) replaced.The ins was actually replaced in (b)(6) 2014.The patient reports they came home from the replacement, but had not been back for their follow up appointment, when they had a heart attack and stroke "5 days post-operative." they went into their femoral artery and the patient told their doctor "they just botched my pacemaker." the ins (stimulator) migration after femoral artery accessed in (b)(6) 2014 related to heart attack.The ins supposed to be in her right side and it migrated all the way over to my belly button, not right on it.When the patient bend down, it turns over on it's side and not lying flat, but turned over.When the patient bend back up, it goes back into place.It was positional.Additional information has been requested but was not available as of the date of this report.A follow-up report will be made if additional information becomes available.

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; product id 3116, serial # (b)(4), product type implantable neurostimulator.(b)(4).

Manufacturer Narrative

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

Event Description

The patient reported that they had a heart attack and a stroke 5 days after their device was implanted.The patient could not drive the distance to their healthcare provider since in 35 minutes they would have been dead.The patient stated that it wasn't good, as they went in and their ¿postops¿ were in the 80s.No further patient complications have been reported as a result of this event.

• 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: lisa woodward clark ; 7000 central avenue ne rcw215; minneapolis, MN 55432 ; 7635263920
• MDR Report Key: 4842327
• MDR Text Key: 5912799
• Report Number: 3004209178-2015-11559
• 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
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 07/12/2017

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: 08/28/2015
• 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: 05/20/2015
• Initial Date FDA Received: 06/12/2015
• Supplement Dates Manufacturer Received: 07/10/2017
• Supplement Dates FDA Received: 07/12/2017
• Date Device Manufactured: 03/07/2014
• 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 Outcome(s): Other; Required Intervention
• Patient Age: 00040 YR