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

Model Number 3116

Device Problems Malposition of Device (2616); Device Operates Differently Than Expected (2913)

Patient Problems Nerve Damage (1979); Paresis (1998); Scar Tissue (2060); Loss of consciousness (2418)

Event Type  Injury  

Event Description

It was reported that patient was having "chronic pain" at the old implant site that felt like ¿stabbing pain.¿ it was indicated that it had been since the neurostimulator ins was moved from the left side to the new position on the right lower quadrant.It was noted that the health care provider hcp implanted the ins midline and it was high, the ins got in the way when patient would bend and he would hit the ins.It was indicated that patient lead wires were across his abdomen, when patient ate he was feeling the lead wires stretch.It was indicated that a new health care provider thought that patient could have nerve damage now.It was noted that since the implant was being moved, at ¿patient¿s old incision site he had being having chronic and drop to his knee pain¿.It was indicated that patient had nerved blocks done but was not helping.It was indicated reporter heard that the scar tissue could be causing the pain.It was indicated that patient actually threatened to commit suicide at original hcp¿s office and the hcp let him leave.It was indicated that patient heard current hcp reporting that original implanter put the ins pocket in the "wrong layer of tissue" but does not have proof of that.The patient was now addicted to oral pain medication from trying to control his pain.It was noted that patient was hospitalized (b)(6) 2013 from pain at the incision site.It was added that nothing was done to patient during his hospital stay.It was reported that patient had episodes where he had pain episodes, it triggers his gastroparesis and then he cannot stop vomiting, he ¿passes out" and get dehydrated.It was noted that his last er visit was (b)(6) 2013 for one of these episodes.It was indicated that this was the longest patient had gone without any hospitalization.It was attributed that patient was taking oral pain medication to manage his pain.A follow-up report will be sent if additional information becomes available.

Manufacturer Narrative

Concomitant medical products: product id: 4351-35, serial# (b)(4), implanted: (b)(4) 2013, product type: lead.Product id: 4351-35, serial# (b)(4), implanted: (b)(4) 2013, product type: lead.Product id: 4351-35, serial# (b)(4), implanted: (b)(4) 2013, product type: lead.Product id: 4351-35, serial# (b)(4), implanted: (b)(4) 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: 3715212
• MDR Text Key: 4249087
• Report Number: 3004209178-2014-05372
• 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
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 03/07/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/31/2014
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 02/28/2014
• Device Model Number: 3116
• Device Catalogue Number: 3116
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 03/07/2014
• Date Device Manufactured: 08/30/2012
• 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; Required Intervention
• Patient Age: 00021 YR