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

Model Number 3116

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Abdominal Pain (1685); Constipation (3274)

Event Type  Injury  

Event Description

It was reported that the patient¿s abdominal pain started earlier in the week and he was admitted to the hospital on (b)(6) 2014.The healthcare provider (hcp) thought the abdominal pain was related to constipation, but that was not entirely clear.The pain could be related to the patient¿s therapy per the reporter.The patient was not having a return of symptoms related to gastroparesis, but the system had not been checked in over four years.The reporter was thus interested in having the system checked.No patient outcome or clear reason for the abdominal pain was reported, so additional information was requested.If additional information is received a supplemental report will be sent.

Event Description

Additional information received from healthcare provider report the patient was seen in clinic and he was admitted to the hospital.They did not have someone come directly to the hospital instead they referred him to two different gi (gastrointestinal) physicians.The patient need to follow upwith them because it wasn¿t an acute issue that they were having with the patient pacer.

Manufacturer Narrative

Product id neu_ptm_prog, serial# unknown; product type programmer, patient product id 435135, serial# (b)(4), implanted: 2007 (b)(6); product type lead product id 435135, serial# (b)(4), implanted: 2007 (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: 4382066
• MDR Text Key: 5122999
• Report Number: 3004209178-2015-00128
• 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: Health Professional
• Reporter Occupation: Health Professional
• Type of Report: Initial,Followup
• Report Date: 12/10/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/05/2015
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 11/14/2008
• Device Model Number: 3116
• Device Catalogue Number: 3116
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 01/14/2015
• Date Device Manufactured: 05/15/2007
• 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: 00026 YR