Model Number 37800 |
Device Problem
Unintended Collision (1429)
|
Patient Problems
Pain (1994); Complaint, Ill-Defined (2331); Weight Changes (2607)
|
Event Date 06/26/2015 |
Event Type
malfunction
|
Manufacturer Narrative
|
If information is provided in the future, a supplemental report will be issued.
|
|
Event Description
|
Information was received from a patient with an implantable neurostimulator (ins) for the treatment of gastrointestinal/pelvic floor and gastric stimulation.It was reported that the patient has been consistently losing weight since implant.They stated that in the last couple of weeks they had lost a ton of weight.They also stated they were hurting when walking around.They reported the ins was sticking out of their gut and it hurt.The patient stated they saw their healthcare professional (hcp) the previous day and they told the patient to get spandex shorts to hold the device in.They stated their intestines on the right side are ¿killing them¿.They also inquired about things they can and cannot eat so that they were not in pain.The patient stated they had a fall on (b)(6) 2019 on the left side and the ins is on the right side.The patient was redirected to their hcp.No further patient complications were 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 was received from a consumer.It was reported that the patient had lost (b)(6).No further complications were reported/anticipated.
|
|
Manufacturer Narrative
|
If information is provided in the future, a supplemental report will be issued.
|
|
Event Description
|
Additional information was received from a consumer.It was reported that the circumstances that led to the fall, pain, and weight loss was that the patient¿s doctor did not give the patient a list of what they could and could not eat.It was noted that nothing was done to resolve the fall, pain, and weight loss.The pain was noted to have been due to the patient¿s gallbladder and the pacemaker had to be turned down to alleviate the pain.No further complications were reported/anticipated.
|
|
Search Alerts/Recalls
|