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

Model Number 3116

Device Problems Migration or Expulsion of Device (1395); Unintended Collision (1429); Unstable (1667)

Patient Problems Pain (1994); Tingling (2171); Dizziness (2194)

Event Date 05/03/2014

Event Type  Injury  

Event Description

It was reported the patient was in an accident on (b)(6) 2014 and their gastric stimulator had dislodged from their abdominal cavity.It was stated the patient was in more pain and had other symptoms such as tingling in their arms and legs and they were feeling like they were going to pass out.It was noted the patient was on their way to the emergency room at the time of report.Additional information from the healthcare provider stated the cause of the event was abdominal trauma and the event was attributed to the implantable neurostimulator (ins).It was noted there was no abnormal impedance measurements.It was stated the patient¿s ins flipped or inverted.The patient had a surgical revision on (b)(6) 2014 and they re-sutured the ins into the pocket.Reportedly, the patient did not require hospitalization and their outcome was reported as non-serious illness or injury.

Manufacturer Narrative

Concomitant medical products: product id 4351-35, serial# (b)(4), implanted: (b)(6) 2014, product type: lead; product id 4351-35, serial# (b)(4), implanted: (b)(6) 2014, 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: 3836621
• MDR Text Key: 4616550
• Report Number: 3004209178-2014-09754
• 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: 05/07/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/28/2014
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 03/28/2015
• Device Model Number: 3116
• Device Catalogue Number: 3116
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 05/07/2014
• Date Device Manufactured: 10/09/2013
• 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: 00041 YR