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

Model Number 3116

Device Problems Battery Problem (2885); Device Operates Differently Than Expected (2913)

Patient Problems Diarrhea (1811); Muscular Rigidity (1968); Nausea (1970); Paresis (1998); Therapeutic Response, Decreased (2271); Complaint, Ill-Defined (2331); Lethargy (2560); Weight Changes (2607); Constipation (3274)

Event Date 04/20/2016

Event Type  malfunction  

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

The health care provider (hcp), consumer, and manufacturer representative reported that the patient had a return of gastroparesis symptoms 2 weeks ago in (b)(6) 2016.The patient had an intermittent or erratic change in therapy.The patient¿s symptoms were waxing and waning on a daily basis.The patient lost weight, had nausea, and had a loss of appetite.The patient had lost 6 lbs.Recently due to a return of symptoms.The patient had an acute return of symptoms including lethargy, diarrhea, constipation, nausea, and lack of appetite starting about 2 to 3 weeks ago in (b)(6) 2016 due to a sudden change.A manufacturer representative shipped a clinician programmer to the hcp and they checked the implantable neurostimulator (ins).The impedances were good, battery life was ok, and the therapy settings were normal.The patient was with their hcps in order to change their programming on (b)(6) 2016 due to a recurrence of symptoms.The hcps didn¿t usually do programming and needed guidance.They had been following another hcp¿s algorithm for programming.They were concerned the implantable neurostimulator (ins) was nearing end of life because their previous ins lasted about 3 years.The patient was programmed to 3.8v, 330 microseconds, 14 hz, and cycling with 3 seconds on and 2 seconds off.The impedance was at 524 ohms with a recommended voltage of 2.6v.The diary was maxed out with the last reset on (b)(6) 2015 and the battery status was ok with longevity of 69 months.The impedances for case and 2 was at 574 ohms, case and 3 was at 574 ohms, and 2 and 3 was at 511 ohms.The patient had not had any active urinary tract infections (utis) and any other underlying medical issues or infections going on.The patient was not pregnant and had not had any changes in medications.The patient was not feeling any shocking with their stimulation.No imaging of the leads had been done.The patient didn¿t fiddle with their ins.No trauma or falls could be related to the issue.The impedance was remeasured at 524 ohms, so the patient was programmed to 10 ma with a voltage of 5.8v and cycling was changed to 0.1 seconds on and 5 seconds off.It was unclear why and when the patient¿s cycling intervals were changed.After changing programming, the patient felt a horizontal band of tightness across their stomach that was more noticeable when sitting or lying and less noticeable when standing and moving around.The tightness was not painful or uncomfortable.The indications for use for this patient were gastric stimulation and gastrointestinal/pelvic floor.

Event Description

Additional information received from the consumer reported that the step taken to resolve the patient's return of symptoms with weight loss, nausea, and a loss of appetite was that the technical service representative worked with the hcp to increase the voltage and alter the patient's on and off cycle.

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; ceiba norte industrial park, r; juncos PR 00777
• Manufacturer (Section G): MEDTRONIC MED REL MEDTRONIC PUERTO RICO; ceiba norte industrial park, r; juncos PR 00777
• Manufacturer Contact: diane wolf ; 7000 central avenue ne rcw215; minneapolis, MN 55432 ; 7635263987
• MDR Report Key: 5726484
• MDR Text Key: 47489562
• Report Number: 3004209178-2016-12222
• 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: company representative,consum
• Reporter Occupation: Health Professional
• Type of Report: Initial,Followup,Followup
• Report Date: 07/05/2016

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: 11/14/2014
• Device Model Number: 3116
• Device Catalogue Number: 3116
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 05/23/2016
• Initial Date FDA Received: 06/15/2016
• Supplement Dates Manufacturer Received: Not provided; 06/13/2016
• Supplement Dates FDA Received: 07/05/2016; 09/23/2017
• Date Device Manufactured: 05/22/2013
• 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 Age: 42 YR