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

Model Number 3116

Device Problems Unexpected Therapeutic Results (1631); Device Operates Differently Than Expected (2913)

Patient Problems Paresis (1998); Therapeutic Effects, Unexpected (2099)

Event Type  Injury  

Event Description

It was reported that the patient never had therapeutic effect.The patient says all the healthcare provider ever does was adjust it but it doesn¿t help.The patient initial implant worked perfect but since the new system (lead and stimulator) were implanted the patient has had no benefit and has been in the hospital with gastroparesis issues approximate twice a year.The patient sees the healthcare provider every three or so months and that was not effective.The patient says that following their recent implant, they was discharged from day-surgery center without the implanting healthcare provider ever checking to see if it was working.The patient notes that their current implant was on '10' and the patient was asked if they mean 10 volts and the patient confirmed yes.The patient notes their original doctor left and went into research and was no longer doing ¿gastro work¿.The patient notes they met with the manufacturer representative 'one time' and he put it at 10 volts and it later had 'falled to a 2'.The patient notes that they only had their initial implant adjusted one time.The patient has an appointment with healthcare provider on (b)(6).The manufacturer representative saw the patient twice and increased the patient settings.

Manufacturer Narrative

Concomitant medical products: product id 435135, serial# (b)(4), implanted: 2011-(b)(6), product type lead, product id 435135, serial# (b)(4), implanted: 2011-(b)(6), 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: 3751125
• MDR Text Key: 4421775
• Report Number: 3004209178-2014-07218
• 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: 03/24/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/15/2014
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 11/28/2012
• Device Model Number: 3116
• Device Catalogue Number: 3116
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 03/24/2014
• Date Device Manufactured: 06/02/2011
• 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
• Patient Age: 00043 YR