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

Model Number 37800

Device Problem Device Operates Differently Than Expected (2913)

Patient Problems Abdominal Pain (1685); Device Overstimulation of Tissue (1991); Sepsis (2067); Complaint, Ill-Defined (2331)

Event Date 05/19/2017

Event Type  Injury  

Event Description

The patient¿s healthcare provider reported that the patient was in the emergency room with abdominal pain, rhythmic pelvic movements, possible overstimulation and sepsis in the abdomen.It was noted that the patient was recently seen by their healthcare provider for some programming changes.The information provided was 464, 10.8, 5.0, 330, 20 and on for 1 second on/4 seconds off.Open: 464, 8.6, 4.0, 4.0, 330 pw, 14 hz and 1 second/4 seconds.The change in the patient¿s therapy/symptoms was reported to be sudden.There were no further complications reported as a result of this event.

Manufacturer Narrative

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

Event Description

Additional information from hcp reported that the cause of the overstimulation was related to a benzo withdrawal.The cause of the abdominal pain, rhythmic pelvic movements, and possible sepsis was also related to the benzo withdrawal.There were no diagnostics performed and the issues had been noted to be resolved.No further complications were reported/anticipated.

Manufacturer Narrative

Corrected information: sex, date of birth 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: lisa woodward clark ; 7000 central avenue ne rcw215; minneapolis, MN 55432 ; 7635263920
• MDR Report Key: 6640479
• MDR Text Key: 77548931
• Report Number: 3004209178-2017-12882
• Device Sequence Number: 1
• Product Code: LNQ
• UDI-Device Identifier: 00643169614246
• UDI-Public: 00643169614246
• 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: Physician
• Type of Report: Initial,Followup,Followup
• Report Date: 08/16/2017

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: 05/28/2018
• Device Model Number: 37800
• Device Catalogue Number: 37800
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 05/20/2017
• Initial Date FDA Received: 06/14/2017
• Supplement Dates Manufacturer Received: 08/04/2017; 08/04/2017
• Supplement Dates FDA Received: 08/16/2017; 09/07/2017
• Date Device Manufactured: 12/01/2016
• 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): Other
• Patient Age: 41 YR
• Patient Weight: 59