MAUDE Adverse Event Report: MEDTRONIC PUERTO RICO OPERATIONS CO. ENTERRA; INTESTINAL STIMULATOR

Model Number 3116

Device Problem Pocket Stimulation (1463)

Patient Problems Hypersensitivity/Allergic reaction (1907); Undesired Nerve Stimulation (1980); Rash (2033)

Event Date 05/01/2016

Event Type  malfunction  

Manufacturer Narrative

If information is provided in the future, a supplemental report will be issued.

Event Description

Information was received regarding a patient implanted for gastric stimulation and gastrointestinal/pelvic floor.The consumer reported a rash suddenly broke out all over her body in the spring time of 2016.Steroids were prescribed but it had not resolved the rash.The healthcare provider believed the patient may have developed an allergy to the stimulator, but an allergy was not confirmed.Additional information received from the healthcare provider reported actions included observation.The rash resolved but the cause was not determined.Additional information from the patient stated that the circumstances that lead to the rash was that they were working in their yard.There no changes with the implantable neurostimulator (ins).The hcp was preparing to do a test to determine what caused the rash as they had been on both topical steroids and pills.The patient stated that the rash was worse and all over their body now.They hoped it was not the "machine" because it was working wonderfully.Additional information from a healthcare provider reported the patient had the rash for about 1.5 years, 2015.The patient had a localized rash and systemic rash due to being sensitized to cobalt and nickel.Symptoms reported included the rash and a stimulation sensation at the ins.No interventions were taken at the time of the report.No further complications were reported/anticipated.

• Brand Name: ENTERRA
• Type of Device: INTESTINAL STIMULATOR
• Manufacturer (Section D): MEDTRONIC PUERTO RICO OPERATIONS CO.; road 31, km. 24, hm 4; ceiba norte industrial park; juncos PR 00777
• Manufacturer (Section G): MEDTRONIC PUERTO RICO OPERATIONS CO.; road 31, km. 24, hm 4; ceiba norte industrial park; juncos PR 00777
• Manufacturer Contact: lisa woodward clark ; 7000 central avenue ne rcw215; minneapolis, MN 55432 ; 7635263920
• MDR Report Key: 7160118
• MDR Text Key: 96630639
• Report Number: 3004209178-2018-00115
• Device Sequence Number: 1
• Product Code: LNQ
• UDI-Device Identifier: 00643169174993
• UDI-Public: 00643169174993
• 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,health professional
• Reporter Occupation: Health Professional
• Type of Report: Initial
• Report Date: 01/03/2018

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: 02/14/2016
• Device Model Number: 3116
• Device Catalogue Number: 3116
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 12/07/2017
• Initial Date FDA Received: 01/03/2018
• Date Device Manufactured: 08/20/2014
• 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: 59 YR