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

Model Number 37800

Device Problems Migration or Expulsion of Device (1395); Impedance Problem (2950)

Patient Problems Pain (1994); Discomfort (2330)

Event Date 08/23/2019

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 healthcare professional (hcp) via a manufacturer representative (rep) regarding a patient who was implanted with a neurostimulator for gastric stimulation.It was reported that the patient had pain at the site of implant and the implant was moving around in the pocket, bothering the patient.It was also noted that impedance values were out of range, so the hcp turned the stimulator off.The patient was scheduled for a re-positioning of the battery for (b)(6) 2019.The issue was not resolved at the time of the report.No 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 was received from a healthcare professional (hcp) via a manufacturer representative.It was reported that the physician repositioned the battery and the impedances normalized.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 MN 00777 1200
• MDR Report Key: 9007929
• MDR Text Key: 160442246
• Report Number: 3007566237-2019-01949
• Device Sequence Number: 1
• Product Code: LNQ
• Combination Product (y/n): N
• PMA/PMN Number: H990014
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Type of Report: Initial,Followup
• Report Date: 10/02/2019

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: 10/28/2020
• Device Model Number: 37800
• Device Catalogue Number: 37800
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 08/29/2019
• Initial Date FDA Received: 09/12/2019
• Supplement Dates Manufacturer Received: 09/23/2019
• Supplement Dates FDA Received: 10/02/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 38 YR