MAUDE Adverse Event Report: MEDTRONIC MED REL MEDTRONIC PUERTO RICO ENTERRA; INTESTINAL STIMULATOR

Model Number 3116

Device Problems Computer Software Problem (1112); Low Battery (2584); Device Displays Incorrect Message (2591)

Patient Problems Nausea (1970); Therapeutic Response, Decreased (2271)

Event Type  Injury  

Manufacturer Narrative

A good faith effort will be made to obtain the applicable information relevant to the report.If information is provided in the future, a supplemental report will be issued.

Event Description

A healthcare professional (hcp) reported an error code that occurred in (b)(6) 2016 noting that when they initially went to battery information screen on the clinician programmer, the battery status was showing as eol (end of life), but the battery check had not been performed yet.A battery check was done and then status was showing ¿low.¿ it was reviewed that the implantable neurostimulator (ins) needed to be replaced and the consumer may not be getting therapy currently.The ins was showing ¿enterra on.¿ the device settings were noted as 8 v, 300 us, 14 hz, 1 s on/ 1 s off, therapy impedance = 456 ohms, and noted recommended voltage was 2.3 v.The consumer had a return of nausea and suspected her therapy was not working and the battery may be dead.The consumer was to follow-up with the hcp.It was noted they planned to replace the ins soon.Indication for use included gastric stimulation.There were no further complications reported and/or anticipated.

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 MED REL MEDTRONIC PUERTO RICO; road 31, km. 24, hm 4; ceiba norte industrial park; juncos PR 00777
• Manufacturer (Section G): MEDTRONIC MED REL MEDTRONIC PUERTO RICO; 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: 6634756
• MDR Text Key: 77392173
• Report Number: 3004209178-2017-12638
• 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: health professional
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 06/12/2017

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: 05/28/2012
• Device Model Number: 3116
• Device Catalogue Number: 3116
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 06/07/2017
• Initial Date FDA Received: 06/12/2017
• Supplement Dates Manufacturer Received: 06/07/2017
• Supplement Dates FDA Received: 10/05/2017
• Date Device Manufactured: 12/10/2010
• 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: 71 YR