MAUDE Adverse Event Report: MDT PUERTO RICO OPERATIONS CO SYNCHROMED II; PUMP, INFUSION, IMPLANTED, PROGRAMMABLE

Model Number 8637-20

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

Patient Problems Abnormal Blood Gases (1034); Dyspnea (1816); Non specific EKG/ECG Changes (1817); Respiratory Distress (2045); Chronic Obstructive Pulmonary Disease (COPD) (2237); Complaint, Ill-Defined (2331); Low Oxygen Saturation (2477); Respiratory Failure (2484)

Event Date 03/21/2017

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

Information was received from a healthcare provider (hcp) via a clinical study regarding a patient who was receiving dilaudid (hydromorphone) (5.0 mg/ml at 1.2391 mg/day), fentanyl (8,000.0 mcg/ml at 1,982.6 mcg/day), and bupivacaine (20.0 mg/ml at 4.957 mg/day) via an implantable pump for non-malignant pain.On (b)(6) 2017, a patient with a history of copd reported sudden increasing shortness of breath, and were brought to the hospital in acute respiratory distress.This occurred after a pump refill and dose increase earlier on the same day.The clinical diagnosis was possible drug side effects.The workup showed severe hypercapnia/acute hypercapnic respiratory failure and copd exacerbation.The patient was intubated and put on mechanical ventilation.An ecg examination showed an unusual p axis, and possible ectopic atrial rhythm with premature atrial complexes, including right bundle branch block.The next day, the patient was admitted to the pulmonary critical care unit.They were treated with solumedrol and a feeding tube was placed.An examination was performed; the patient was awake and could nod yes and no before falling back asleep.Lab testing was performed; blood gases revealed severe hypercapnia and copd exacerbation.A chest x-ray showed no focal infiltrated and the endotracheal tube in place.An abdominal x-ray showed the feeding tube in place.Per the hcp assessment, the patient most likely had chronic hypoxemia.They also noted the hypercapnic respiratory failure, and the pump was most likely contributing to the hypercapnia.An examination was performed on (b)(6) 2017.The patient was stable after treatment with solumedrol and extubation.They were discharged home on a tapering steroid dose.The event resulted in in-patient hospitalization, an er visit, a life-threatening illness/injury, and the use of medical/surgical intervention to prevent life threatening illness/injury or permanent impairment to body structure/function.The event was possibly related to the device/therapy, and not related to the implant procedure.The event was possibly related to the drug.The drug action that caused the event was an increase in dose.The event was considered ongoing.No further complications were reported or anticipated.Additional information was received.The event resolved without sequelae on (b)(6) 2017.Additional information was received from a hcp via a manufacturer¿s representative.The representative stated that the patient was admitted to the hospital 1 to 2 days after the refill/dose increase, although this conflicts with the information provided earlier.

Manufacturer Narrative

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

• Brand Name: SYNCHROMED II
• Type of Device: PUMP, INFUSION, IMPLANTED, PROGRAMMABLE
• Manufacturer (Section D): MDT PUERTO RICO OPERATIONS CO; rd 31 km 24 hm 4; juncos PR 00777
• Manufacturer (Section G): MDT PUERTO RICO OPERATIONS CO; rd 31 km 24 hm 4; juncos PR 00777
• Manufacturer Contact: lisa woodward clark ; 7000 central avenue ne rcw215; minneapolis, MN 55432 ; 7635263920
• MDR Report Key: 6523126
• MDR Text Key: 73780866
• Report Number: 3004209178-2017-09115
• Device Sequence Number: 1
• Product Code: LKK
• UDI-Device Identifier: 00613994779229
• UDI-Public: 00613994779229
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P860004
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 04/26/2017

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: 09/28/2013
• Device Model Number: 8637-20
• Device Catalogue Number: 8637-20
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 03/29/2017
• Initial Date FDA Received: 04/26/2017
• Supplement Dates Manufacturer Received: 03/29/2017
• Supplement Dates FDA Received: 10/03/2017
• Date Device Manufactured: 04/12/2012
• 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; Life Threatening; Required Intervention
• Patient Age: 71 YR
• Patient Weight: 102