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 Abdominal Pain (1685); High Blood Pressure/ Hypertension (1908); Nausea (1970); Tachycardia (2095); Vomiting (2144); Electrolyte Imbalance (2196); Distress (2329); Discomfort (2330); Complaint, Ill-Defined (2331); Abdominal Distention (2601); Test Result (2695)

Event Date 01/29/2002

Event Type  Injury  

Event Description

It was reported that the patient was admitted to the hospital with symptoms of nausea and vomiting on (b)(6) 2002.No treatment/interventions, outcome, medical status prior to the event, or differential diagnosis for the event was reported regarding the patient¿s hospitalization.Approximately 4 months later, the patient felt fine after a scheduled dialysis but later that night the patient began having abdominal pain and nausea which lead to uncontrollable emesis.The patient reportedly seen ¿every 1-2 weeks¿ because they had chronic repeated episodes of severe nausea and vomiting, with extreme hypertension during these episodes, in which were generally able to be controlled with emergency room treatment.However, the symptoms were not able to be controlled the following day on (b)(6) 2002 despite being treated with multiple doses of medicine.The patient was admitted with accelerated hypertension secondary to nausea and vomiting.Patient also had symptoms related to underlying conditions including poorly controlled diabetes, mildly increased blood sugar, poorly controlled diabetes, renal insufficiency/end-state renal disease, and dialysis resulting in six liters of fluid being removed.During admission, the patient¿s blood pressure was approximately 260/100 to 264/159 and the heart rate was elevated to 128 beats per minute.A physical exam determined that there were ¿mildly decreased breath sounds¿ and the abdomen showed ¿mild diffuse tenderness to palpation¿ as well as mild distention.The patient was in ¿moderate distress¿ secondary to abdominal pain with observed emesis.Diagnostic procedures were performed including electrocardiogram which showed tachycardia and x-rays of the kidney, ureters, and bladder.Laboratory results showed ¿mildly increased¿ white blood cell count that was ¿likely¿ secondary to stress, ¿infectious disease,¿ and an anion gap.It was noted that medications were administered and the patient received hemodialysis.The nicardipine drip showed moderate improvement in blood pressure, and then the blood pressure steadily declined to 110/70 during dialysis.After the drip and hemodialysis were discontinued, the patient¿s high blood pressure remained stable and the patient restarted on regular medications.It was noted that the gastrointestinal doctor will be consulted regarding the device given the frequency of symptoms.The event ended on (b)(6) 2002 and the patient recovered from the event.Follow-up is being conducted for clarification of the hospitalization on (b)(6) 2002.If additional information is received, a follow-up report will be sent.

Manufacturer Narrative

Product id: 435135, serial# (b)(4), implanted: (b)(6) 2002, product type: lead.Product id: 435135, serial# (b)(4), implanted: (b)(6) 2002, 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: 4064318
• MDR Text Key: 4895844
• Report Number: 6000032-2014-00182
• 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: 02/01/2002

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/05/2014
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 02/14/2003
• Device Model Number: 7425G
• Device Catalogue Number: 7425G
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 02/01/2002
• Date Device Manufactured: 08/24/2001
• 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: 00033 YR