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

Model Number 37800

Device Problems Inappropriate/Inadequate Shock/Stimulation (1574); Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Abdominal Pain (1685); Bacterial Infection (1735); Unspecified Infection (1930); Muscle Spasm(s) (1966); Pain (1994); Sepsis (2067); Complaint, Ill-Defined (2331); Electric Shock (2554); Weight Changes (2607)

Event Date 06/01/2018

Event Type  Injury  

Manufacturer Narrative

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

Event Description

Information was received from a consumer (con) regarding a patient who was implanted with a neurostimulator for gastric stimulation.It was reported that the patient had complications and infections.No device issues or further complications were reported or anticipated.

Manufacturer Narrative

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

Event Description

Additional information from the consumer on (b)(6) reported complications, uncontrollable pain, and infections and she had already talked to her healthcare professional (hcp).

Manufacturer Narrative

Patient code c26726 no longer applies.If information is provided in the future, a supplemental report will be issued.

Event Description

Additional information from the consumer regarding the patient with an implantable neurostimulator (ins) on (b)(6) reported the gastric device was causing her sepsis and complications.It was noted the patient was transferred to patient services.The patient stated she had notified the hcp and per the patient the hcp checked the stimulator and said the stimulator was working fine and couldn¿t explain her abdominal pain and abdominal spasms.The patient noted the spasms and pain occurred daily.The patient noted the spasms and abdominal pain began the day of implant on (b)(6), 2018.The patient stated 2 weeks post implant the patient started experiencing shocking when she would eat and as a result the patient lost (b)(6) lbs, and the patient stated she was around (b)(6) lbs at the time of implant.The patient notified the hcp and the hcp reported it was abnormal.The patient noted she sent a video of the shocking of the abdomen to her hcp.The patient stated the hcp turned down the stimulation, however, they would not turn stimulation off.The patient noted she was referred to a malabsorption specialist.The patient stated the shocking wasn¿t as bad when stimulation was turned down.The patient discussed the situation with their parents and due to the distance to the specialist, they decided to work with a gastrointestinal hcp who was very experienced with gastroparesis and nutritionist and they developed a plan for her.The patient was hospitalized and give total parental nutrition.The patient stated the feeding port was removed and it was determined that was not the source of infection and the patient said that the only other implant they had was the gastric system.The patient noted the infection was confirmed and there was sepsis, gastrointestinal, bacteria.The patient noted the infection began in the middle of august and they went to the emergency room (er) and was diagnosed with sepsis.The patient was given 2 oral antibiotics.The patient was concerned the gastric stimulation system could be the source of infection and would like the system explanted.Additional information from the patient on (b)(6)reported they called the hcp and the hcp stated after looking over all the patient¿s medical record the hcp said they would not absolutely not removed the enterra device.The patient noted an hcp believed the device was the source of the infection because it was a gastrointestinal bacteria infection.The patient stated the sepsis would not clear up until the patient¿s device was removed.There were no further complications that have been 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 received from a healthcare professional (hcp).It was reported that no infection was noted on the patient¿s last visit on (b)(6) 2018.The patient had not followed-up since then.

• 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: 7918835
• MDR Text Key: 122043305
• Report Number: 3004209178-2018-21793
• 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: consumer,health professional
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup,Followup,Followup
• Report Date: 12/18/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/28/2018
• Is this an Adverse Event Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 08/28/2019
• Device Model Number: 37800
• Device Catalogue Number: 37800
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 12/07/2018
• Date Device Manufactured: 03/13/2018
• 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; Life Threatening; Required Intervention
• Patient Age: 27 YR
• Patient Weight: 34