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

Model Number 3116

Device Problems Inappropriate/Inadequate Shock/Stimulation (1574); Electromagnetic Compatibility Problem (2927)

Patient Problem Fall (1848)

Event Type  malfunction  

Event Description

It was reported that patient's shocking feeling when she had this device.It was noted that when the patient was at the library and went to the front desk to receive a fax, she felt a jolt once and then she felt a real jolt the second time and it felt in her knees a little bit and it hurt.Then, as she was walking away from the front desk, she felt the jolting sensation the 3 rd.Time and she went down on her knees and told her son there was a magnet around and she got shocked.She got shocked and also it burned the surrounding area.She told the library they got to put a sign for people to know that there was a magnet.The patient called health care provider (hcp) the same day and made health care provider (hcp) aware.Next day she went to hcp and the device was checked.The patient mentioned she was still hurting the next day.No further information was reported.Further follow up is being conducted to obtain additional information.A follow-up report will be sent if additional information becomes available.

Manufacturer Narrative

Concomitant medical products: product id: 435135, serial# (b)(4), implanted: (b)(6) 2010, product type: lead.Product id: 435135, serial# (b)(4), implanted: (b)(6) 2010, 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: 4914059
• MDR Text Key: 18632867
• Report Number: 3004209178-2015-13378
• 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: 06/22/2015

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: 07/28/2014
• 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: 06/22/2015
• Initial Date FDA Received: 07/14/2015
• Date Device Manufactured: 02/08/2013
• 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 Age: 00046 YR