MAUDE Adverse Event Report: MEDTRONIC NEUROMODULATION SYNCHROMED II; PUMP, INFUSION, IMPLANTED, PROGRAMMABLE

Model Number 8637-20

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

Patient Problems Sedation (2368); Cognitive Changes (2551)

Event Date 06/18/2015

Event Type  Injury  

Manufacturer Narrative

Concomitant medical products: product id 8590-1, lot# n213449, implanted: (b)(6) 2009, product type: accessory.Product id 8711, serial# (b)(4), implanted: (b)(6) 2009, product type: catheter.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 had been having symptoms of sedation and a change in mental status that had started about a week prior to (b)(6) 2015.The patient¿s pump managing physician had been contacted.The patient was currently at another medical center and the physician there wanted the pump interrogated.The device system was delivering fentanyl and bupivacaine.The interventions and cause of the symptoms were not reported.Further follow-up is being conducted to obtain this information.Additional information received from the healthcare provider (hcp).It was unknown what diagnostics were performed related to the sedation and change in mental status.The total daily dose (tdd) was decreased by 10% to resolve the sedation and change in mental status.The cause of the symptoms were not determined.Additional information was received from a healthcare provider (hcp) via a clinical study.The patient was receiving fentanyl (3,000.0 mcg/ml at 1,048.1 mcg/day) and bupivacaine (5.0 mg/ml at 1.7469 mg/day) via an implantable pump for non-malignant pain, failed back surgery syndrome, and post lumbar laminectomy syndrome.On (b)(6) 2015, the patient was seen in the hospital.The patient was ¿monitored in hospital out of area¿ on (b)(6) 2015.The patient¿s care was to be transferred.The patient was admitted to the hospital for oversedation.The event required in-patient or prolonged hospitalization.The clinical diagnosis was ¿patient was admitted to hospital for oversedation.¿ the event resulted in an emergency room visit.The event was possibly related to the device/therapy.The event was not related to the implant procedure.The event was possibly related to the drug (fentanyl/bupivacaine).There was no change in the drug that caused the event.The event resolved without sequelae on (b)(6) 2015.

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): MEDTRONIC NEUROMODULATION; 800 53rd ave ne; minneapolis MN 55421 1200
• Manufacturer (Section G): MEDTRONIC NEUROMODULATION; 800 53rd ave ne; minneapolis MN 55421 1200
• Manufacturer Contact: lisa clark ; 7000 central avenue ne rcw215; minneapolis, MN 55432 ; 7635263920
• MDR Report Key: 6341374
• MDR Text Key: 67801913
• Report Number: 3007566237-2017-00720
• Device Sequence Number: 1
• Product Code: LKK
• 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: health professional,study
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 02/17/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/17/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 11/14/2010
• Device Model Number: 8637-20
• Device Catalogue Number: 8637-20
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 01/29/2017
• Date Device Manufactured: 05/20/2009
• 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): Hospitalization
• Patient Age: 73 YR