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

Model Number 3116

Device Problems Inappropriate/Inadequate Shock/Stimulation (1574); Electro-Static Discharge (2149)

Patient Problems Complaint, Ill-Defined (2331); Electric Shock (2554)

Event Date 06/04/2016

Event Type  Injury  

Event Description

The consumer reported that the patient drove into a lightning storm on 2016-06-04 and this might have affected their stimulator.The patient was experiencing shocking and a lot of gastrointestinal symptoms with it.The patient's primary health care provider (hcp) requested a clinician programmer and the patient wanted to know if it had been sent to the location.The hcp initially wanted the remote for a normal appointment, but now wanted it sooner because the patient was being shocked.They used to send the remote to the hcp all the time.The indication for use for this patient was gastrointestinal/pelvic floor.

Event Description

Additional information received from the patient reported adjustments failed to help with the shocking.The patient received a new device and had an omentum flap surgery with it on (b)(6) 2016.Following the procedure, the patient did not have shocking and the gastrointestinal symptoms had resolved.The patient was at a much higher setting and they did not have to take any daily medications for gastrointestinal symptoms, pain, or dysautonomia.

Manufacturer Narrative

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

• 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: diane wolf ; 7000 central avenue ne rcw215; minneapolis, MN 55432 ; 7635263987
• MDR Report Key: 5751766
• MDR Text Key: 48305938
• Report Number: 3004209178-2016-12951
• 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,Followup,Followup
• Report Date: 09/22/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/27/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 04/14/2016
• Device Model Number: 3116
• Device Catalogue Number: 3116
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 08/26/2016
• Date Device Manufactured: 10/17/2014
• 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 Outcome(s): Required Intervention
• Patient Age: 23 YR