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 Diarrhea (1811); Nausea (1970); Hernia (2240); Complaint, Ill-Defined (2331); Disability (2371)

Event Type  Injury  

Event Description

It was reported that the patient had a hiatal hernia and in let patch.Diagnostic procedures included an esophagogastroduodenoscopy which revealed hiatal hernia.There were no surgeries or therapeutic actions.The patient was reportedly hospitalized for two nights, improving with hydration and home medications.Patient had some nausea and loose stool, but felt ¿okay¿ except her ¿h/n¿ dropped.It was stated that the event ended on (b)(6) 2000 as the patient recovered from the event with therapeutic action, but then stated that the event continued.Permanent disability was noted.Final outcome and cause/type of permanent disability was not given.Follow-up is being conducted to obtain this.If any additional information is received, a supplemental report will be sent.

Manufacturer Narrative

Concomitant medical products: product id: 4301-35, serial# (b)(4), product type: lead.Product id: 4301-35, 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: 4189499
• MDR Text Key: 5022746
• Report Number: 6000032-2014-00248
• 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: 06/21/2001

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: 06/21/2001
• Initial Date FDA Received: 10/21/2014
• 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; Disability
• Patient Age: 00052 YR