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

Model Number	8637-40
Medical Device Problem Codes	Fluid/Blood Leak (1250); Kinked (1339); Aspiration Issue (2883)
Health Effect - Clinical Code	Pain (1994)
Date of Event	03/01/2018
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Concomitant medical products: product id: 8637-40, serial# (b)(4), implanted: (b)(6) 2014, product type: pump.Other relevant device(s) are: product id: 8637-40, serial/lot #: (b)(4), (b)(6), (b)(4).If information is provided in the future, a supplemental report will be issued.
Event or Problem Description
Information was received from a healthcare provider via a clinical study regarding a patient receiving hydromorphone (10.0 mg/ml at 2.0 mg/day), fentanyl (1515.0 mcg/ml at 310.0 mcg/day), and bupivacaine (9 mg/ml at 1.8 mg/day) via an implanted pump.The indication for use was spinal pain.It was reported the patient's pain was more intense compared to the pain they had previously had.It was noted the change was due to a fall.No environmental factors were contributing to the loss of pain control.A catheter dye study was performed, on (b)(6) 2018, and a leak was detected.It was noted the pump originally didn't aspirate and only when manipulated did fluid start to come out.There was also a leak at the anchor site at l1 with intrathecal contrast noted.A kink was found at the collette.It was indicated the event was possible related to the device or therapy and unlikely related to the implant procedure.The device diagnosis was catheter leakage and the clinical diagnosis was increase in pain.The patient's catheter was explanted and not replaced on (b)(6) 2018.It was noted the catheter was returned to the manufacture.The issue resolved without sequelae on (b)(6) 2018.It was noted the patient was also taking hydrocodone, keflex, mvi, omepreazole, sertraline, vistaril, wellbutrin at the time of the event.The patient's medical history included post laminectomy syndrome, sleep apnea, arachnoidits, seizure disorder, depression.The patient's weight was noted as (b)(6).
Additional Manufacturer Narrative
Analysis results were not available at the time of this report.A follow-up report will be sent when analysis is completed.If information is provided in the future, a supplemental report will be issued.
Event or Problem Description
Additional information received from healthcare provider (hcp) via clinical study indicated the catheter was explanted and replaced on (b)(6) 2018.No further complications were reported/anticipated.
Additional Manufacturer Narrative
The catheter was returned, and analysis found a kink in the catheter body and a hole-not user related in the catheter body.If information is provided in the future, a supplemental report will be issued.

• Brand Name: SYNCHROMED II
• Common Device Name: PUMP, INFUSION, IMPLANTED, PROGRAMMABLE
• Manufacturer (Section D): MEDTRONIC NEUROMODULATION; 800 53rd ave ne; minneapolis MN 55421 1200
• MDR Report Key: 7518610
• Report Number: 3007566237-2018-01471
• Device Sequence Number: 1224714
• Product Code: LKK
• UDI-Device Identifier: 00613994555601
• UDI-Public: 00613994555601
• Combination Product (Y/N): N
• Initial Reporter State: WI
• Initial Reporter Country: US
• PMA/510(K) Number: P860004
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2014
• Reporter Type: Manufacturer
• Report Source: consumer,health professional
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 05/31/2018

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?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 12/28/2015
• Device Model Number: 8637-40
• Device Catalogue Number: 8637-40
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/16/2018
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/10/2018
• Supplement Date Received by Manufacturer: 05/18/2018; 05/30/2018
• Initial Report FDA Received Date: 05/16/2018
• Supplement Report FDA Received Date: 05/18/2018; 05/31/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 55 YR
• Patient Weight: 80