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

Model Number 3116

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Low Blood Pressure/ Hypotension (1914); Nausea (1970); Pain (1994); Renal Failure (2041); Scar Tissue (2060); Urinary Retention (2119); Discomfort (2330); Complaint, Ill-Defined (2331); Reaction (2414); Cognitive Changes (2551); Lethargy (2560); Test Result (2695)

Event Date 04/09/2009

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

The patient reported that on (b)(6) 2009, the day after they were implanted, they had so much scar tissue that their kidney shut down.They indicated that they were in the icu.There were no further complications reported as a result of this event.The indication for use was gastric stimulation.

Manufacturer Narrative

If information is provided in the future, a supplemental report will be issued.

Event Description

Additional information received from the patient indicated that during the implant surgery, their kidneys shut down.They woke up in the icu, and the surgeon told them they were in the icu due to their kidneys shutting down.The surgeon stated that there was more scar tissue in the abdomen cavity than he had anticipated.This caused the implant to be a "disaster going in" and the surgery to last a lot longer.It was supposed to last 2-3 hours, but ended up taking 9 hours.The patient stated that the surgeon should have backed out when they encountered that much scar tissue.There were no further complications reported as a result of this event.

Manufacturer Narrative

Patient code of (b)(4) was removed as it no longer applied to this event.If information is provided in the future, a supplemental report will be issued.

Event Description

Additional information received from the healthcare provider (hcp) indicated that the scar tissue was not related to the patient's underlying condition.From the operative report on (b)(6)2009, it was noted that there were moderate amounts of adhesions in the right upper quadrant secondary to an open cholecystectomy.During the procedure, moderate amounts of adhesions were encountered involving the distal stomach and prepyloric regions.The adhesions were bluntly and sharply divided with the use of electrocautery, identifying the pylorus measuring approximately 10 cm.The leads were sutured in place, connected to the generator, and placed in the pocket.Impedance values were 579 before and after the system was placed in the pocket.Normal settings were accepted.It was noted that the patient tolerated the procedure well, and was taken to recovery in stable condition.In the discharge summary on (b)(6)2009, it was indicated that the patient's secondary diagnosis included: nonalcoholic steatohepatitis, obstructive sleep apnea, gastroesophageal reflux disease, hypothyroidism, bipolar disorder, osteoarthritis, posttraumatic stress disorder, obesity, and psoriasis.Medications included: lantus insulin, seroquel, trazodone, ambien, cymbalta, celexa, valium, synthroid, and zofran.The abdominal exam showed generalized tenderness even on light palpation.The patient had surgical lesions on their hands.Lab work showed a wbc count of 5, h and h of 12.5/36.8,platelets 214,000, bun and creatinine 10/0.8, sodium 141, potassium 3.9, alkaline phosphatase elevated to 165, sgot up to 65, sgpt up to 51, total bilirubin was 0.6, magnesium was 2.3, lipase 29, and the urinalysis was essentially negative.A chest x-ray showed minimal linear scarring or atelectasis in the left lower lung.Ekg showed normal sinus rhythm with nonspecific st-t wave abnormalities.When this was compared to a prior ekg tracing, no changes were found.It was noted that a hcp performed an intraoperative gastroscopy to verify gastric leads did not penetrate the stomach.Postoperatively, the patient was continued on iv fluids and allowed same prehospital medications.The patient's glucose was controlled with an insulin sliding scale, they were given pepcid for ulcer prevention, and were give zofran for nausea.The patient was allowed dilaudid by mouth for pain control.The following day, the patient was started on lovenox for additional deep vein thrombosis prophylaxis.They developed an episode of decreased mental status and hypotension that required transfer to the critical care unit.Workup was essentially negative including troponins, blood glucose, ekg, and chest x-ray.A foley catheter was placed.Repeat stat blood labs were essentially normal.The hcp thought that the patient's seroquel dosage was too high, and they were lethargic from this and the combination of their pain medications.The pain medications and seroquel were withheld.Over the next several days, the patient's mental status returned to baseline.It was noted that the patient was well enough for discharge, afebrile, tolerating a regular diet, urinating with the foley catheter out, and ambulating.The abdominal incision was clear with minimal tenderness.The patient was instructed regarding diet, activity, and wound care.A prescription was written for dilaudid 2 mg by mouth, every 6 hours, as needed.The discharge medications included: celexa, valium, cymbalta, lantus insulin, synthroid, seroquel, trazodone, ambien, dilaudid, and prilosec.There were no further complications reported as a result of this event.

• 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: 6763735
• MDR Text Key: 81716549
• Report Number: 3004209178-2017-16156
• 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,health professional
• Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date: 10/10/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/03/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 08/14/2010
• Device Model Number: 3116
• Device Catalogue Number: 3116
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 09/12/2017
• Date Device Manufactured: 02/24/2009
• 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): Life Threatening
• Patient Age: 50 YR
• Patient Weight: 141