MAUDE Adverse Event Report: MDT SOFAMOR DANEK PUERTO RICO MFG ENTERRA; INTESTINAL STIMULATOR

Model Number 7425G

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

Patient Problems Nausea (1970); Vomiting (2144); Weakness (2145); Electrolyte Imbalance (2196); Complaint, Ill-Defined (2331); No Code Available (3191)

Event Date 01/18/2001

Event Type  Injury  

Event Description

It was reported that ¿several weeks¿ after implant, the patient began vomiting and was noted to be dehydrated and hypokalemic.The patient ¿generally¿ felt weak and did have ¿some orthostatic symptoms¿ when she stood.It was stated that the patient ¿intermittently¿ had required total parenteral nutrition (tpn) to maintain her nutrition.The patient reportedly needed daily intravenous (iv) fluids with potassium supplements to maintain her electrolyte balance.It was noted that it ¿finally got so bad it was felt hospitalization was necessary.¿ the patient began to have abdominal pain soon after admission and had to go on morphine sulfate for relief.Though, it was later stated that the patient reported began having abdominal pain ¿several days after hospitalization¿ and required morphine sulfate every four hours for pain relief.Tpn was continuously used for nutritional needs as well as pepcid drip and prevacid.An upper esophagogastroduodenoscopy was performed on (b)(6) 2001, which showed only mild duodenitis and a ct scan was performed which was normal.Temperature, albumin, creatinine, glucose, and blood pressure were unremarkable.The patient required a ¿pick line¿ which became ¿plugged¿ and was removed, leading to surgical placement of port-a-cath.The patient had ¿excess g-tube output¿ with poor nutrition and ¿continued to remain severely hypokalemic,¿ so tpn was instituted.It was noted that the patient ¿hardly had any veins that were even visible.¿ the patient was reportedly discharged with medications on (b)(6) 2001.The discharge summary reported that the patient had nausea secondary to her preexisting gastroparesis condition.The patient¿s condition on discharge was ¿improved.¿ additional information was requested.

Manufacturer Narrative

Concomitant medical products: product id: 4351, serial# (b)(4), product type: lead.Product id: 4351, serial# (b)(4), product type: lead.(b)(4).

• Brand Name: ENTERRA
• Type of Device: INTESTINAL STIMULATOR
• Manufacturer (Section D): MDT SOFAMOR DANEK PUERTO RICO MFG; barrio marianna rd 909, km0.4; humacao PR 00792
• 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: 4031516
• MDR Text Key: 15324814
• Report Number: 6000032-2014-00172
• 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: Study,Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 09/21/2001

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?: No
• Device Operator: Health Professional
• Device Expiration Date: 02/28/2002
• Device Model Number: 7425G
• Device Catalogue Number: 7425G
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 09/21/2001
• Initial Date FDA Received: 08/22/2014
• Date Device Manufactured: 09/11/2000
• 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): Hospitalization; Required Intervention
• Patient Age: 00038 YR