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

Model Number 3116

Device Problem Device Operates Differently Than Expected (2913)

Patient Problems Muscle Spasm(s) (1966); Seizures (2063)

Event Type  Injury  

Event Description

It was reported that 2 weeks after surgery the patient had the device turned up a little.The patient was having spasms like he was having seizures.The patient had to call an ambulance.The hcp (healthcare provider) told him it was just because his body wasn't used to the device.The doctor turned the device down and the spasms went away.

Manufacturer Narrative

Concomitant products: product id: 4351-35, serial# (b)(4), implanted: (b)(6) 2013, product type: lead.Product id: 4351-35, serial# (b)(4), implanted: (b)(6) 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: 3659432
• MDR Text Key: 4198744
• Report Number: 3004209178-2014-03932
• 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: 02/14/2014

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: 08/28/2014
• 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: 02/14/2014
• Initial Date FDA Received: 03/05/2014
• Date Device Manufactured: 03/08/2013
• 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): Other
• Patient Age: 00031 YR