MAUDE Adverse Event Report: MEDTRONIC NEUROMODULATION ENTERRA; INTESTINAL STIMULATOR

Model Number 435135

Device Problems Pocket Stimulation (1463); Inappropriate/Inadequate Shock/Stimulation (1574); Low impedance (2285)

Patient Problems Abdominal Pain (1685); Muscle Spasm(s) (1966); Undesired Nerve Stimulation (1980); Pain (1994); Therapeutic Response, Decreased (2271); Complaint, Ill-Defined (2331); Neck Pain (2433); Sleep Dysfunction (2517); Electric Shock (2554)

Event Type  malfunction  

Manufacturer Narrative

Concomitant medical products: product id: 435135, serial# (b)(4), implanted: (b)(6) 2011, product type: lead.Product id: 3116, serial# (b)(4), implanted: (b)(6) 2011, explanted: (b)(6) 2015, product type: implantable neurostimulator.Product id: 435135, serial# (b)(4), implanted: (b)(6) 2011, product type: lead.(b)(4).

Event Description

The patient reported on (b)(6) 2015 that they were getting shocked at implantable neurostimulator (ins) site on left and right side and had a loss of therapy.The patient reported she does not have an appetite and was getting sicker and sicker as time goes on and reported 10 pound weight loss since (b)(6) 2015.There was no fall or trauma reported with regards to this event.The patient reported pain radiating up her back and neck and giving her migraines since (b)(6) 2015.The patient stated that she went to her health care provider's (hcp) office last week who read her ins battery and patient was told it said "7.9" and was 'low".The hcp stated that the reading did not make sense but patient states hcp did not re-test it.It was reported that about a week later the hcp off the stimulator on (b)(6) 2015 and surgery was scheduled for a new battery put in on (b)(6) 2015.It was turned off to stop the pain.The patient stated they had to deal with the pain, loss of appetite, try to eat, it's been difficult and patient could not believe they would leave her with stimulator off for 3 weeks.The patient was hopeful that the surgery with the new battery will feel better eventually.The patient requested a phone numbers of hcp for future problems when stimulator needs to be replaced when dead.No further information was reported.Further follow up is being conducted to obtain additional information.Additional information received from the consumer on (b)(6) 2015 reported that there was a loss of therapy and shocking that was occurring daily.There was pain in the stomach that was considered a sudden change.Her implantable neurostimulator (ins) was turned off two weeks before it was removed.They turned it off around (b)(6) 2015 because it was causing abdominal pain and severe back spasm.There were all kinds of problems and it was shocking and hurting the patient.When asked about the reason for replacement, the patient said it was low and it had 78 months left on it.The symptoms started two weeks before (b)(6) 2015.The patient felt that the leads were causing the back spasms and shocking.It was also reported that the new ins was causing her pain and she could not "go." she was taking all kinds of stuff and it was causing back spasms up their back and up their neck.The patient was "up all night long be cause their stomach the pit in where the leads were attached." she wanted the leads to be replaced and told her health care professional (hcp) this.The patient was taking soma with a pain pill every four hours.They woke up all hours of the night, several times a night.The pain in the stomach started before they turned off their old ins.The pain had been worse since getting the new ins.After they ate, it was like everything was sitting right there and nothing was moving.It was like the leads were compacting.The patient felt that the leads were causing the back spasms and shocking.They did an impedance test and it was low and shocking her.The health care professional (hcp) did x-rays and said maybe the cords got crossed but when the hcp checked, they were not crossed.The first surgeon did none of it right and the leads may look ok, but the patient did not feel like it was acting ok.The patient felt that the leads were causing the back spasms and shocking.The indications for use for this patient gastric stimulation and gastrointestinal/pelvic floor.A follow-up report will be sent if additional information becomes available.Please see manufacturer report #3004209178-2015-23127 and #3007566237-2015-03842 for information on the patient's concomitant system (ins and lead, respectively).

• Brand Name: ENTERRA
• Type of Device: INTESTINAL STIMULATOR
• Manufacturer (Section D): MEDTRONIC NEUROMODULATION; 800 53rd ave ne; minneapolis MN 55421 1200
• Manufacturer (Section G): MEDTRONIC NEUROMODULATION; 7000 central avenue ne rcw215; minneapolis MN 55432
• Manufacturer Contact: diane wolf ; 7000 central avenue ne rcw215; minneapolis, MN 55432 ; 7635263987
• MDR Report Key: 5298600
• MDR Text Key: 34138390
• Report Number: 3007566237-2015-03843
• 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: consumer
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 11/19/2015

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: 07/13/2013
• Device Model Number: 435135
• Device Catalogue Number: 435135
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 11/19/2015
• Initial Date FDA Received: 12/15/2015
• Date Device Manufactured: 07/13/2011
• 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: 00048 YR