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

Model Number 8637-40

Device Problems Material Integrity Problem (2978); Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Syncope (1610); Chest Pain (1776); Dyspnea (1816); Unspecified Infection (1930); Nausea (1970); Overdose (1988); Pain (1994); Vomiting (2144); Burning Sensation (2146); Therapeutic Response, Decreased (2271); Anxiety (2328); Depression (2361); Test Result (2695)

Event Date 10/10/2018

Event Type  Injury  

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 Description

Information was received from a healthcare provider via a company representative regarding a patient receiving morphine 25mg/ml at 2 5mg/day via an implantable pump.The indications for use were non-malignant pain, chronic low back pain and failed back surgery syndrome.On (b)(6) 2018 it was reported that the patient was admitted to the ed (emergency department) for symptoms of burning in chest and shortness of breath with a syncopal event.The patient was approximately 2 weeks post op for tdd (targeted drug delivery) pump replacement.The patient was admitted in-patient and has experienced nausea and vomiting as well as elevated wbc¿s (white blood cell).It was noted that the patient¿s chronic pain was effectively controlled with tdd (targeted drug delivery).At the time of the report, there were no noted environmental, external or patient factors that may have led or contributed to the issue.Per the physician¿s request, the patient was scheduled for a catheter dye study on (b)(6) 2018.No actions or interventions were planned at the time of the report.The issue was not resolved at the time of the report and it was noted that the healthcare provider would not have any further information regarding the event.The patient status was noted as alive, no injury.Additional information received on (b)(6) 2018 from the healthcare provider via the company representative reported that the actions and interventions taken to resolve the patient¿s symptoms were the patient was being treated in-patient for nausea/vomiting and infection of unknown origin.The cause was not yet determined.Additional information was received on (b)(6) 2018 that reported that the patient was still symptomatic from 3 weeks ago.The patient¿s symptoms were increased pain, chest pain and pocket pain.Per this reporter, they did a cap (catheter access port) and dye study on (b)(6) 3018 and it was non-conclusive.On implant they only had concentration 25mg/ml of morphine and the pump was filled.The patient had been getting 50mg/ml in the old pump.Today they would change out the 25mg/ml of morphine to 50mg/ml.Additional information was received on (b)(6) 2018 at which time it was reported that the pump and catheter were replaced at the recommendation of the neurosurgeon.After a second dye study (date not reported) there were no issues found, but the patient was still symptomatic.The patient was having withdrawal and overdose symptoms of nausea, vomiting, depression, and anxiety.The patient had been experiencing therapeutic relief since the replacement 2-3 weeks ago.For good measure the neurologist wanted a ¿clean slate¿ and wanted to start off with a brand new pump and catheter.No further complications were reported or anticipated.

Manufacturer Narrative

Product id neu_unknown_cath, serial# unknown, explanted: (b)(6) 2018.Information references the main component of the system.Other relevant device(s) are : product id: neu_unknown_cath, serial# unknown, ubd unknown, udi# asku.Analysis of the pump revealed no anomaly.Analysis of the unknown catheter revealed sc connector- coring-tears-cut in seal.If information is provided in the future, a supplemental report will be issued.

Manufacturer Narrative

Product id: 8578, serial# (b)(4), implanted: (b)(6) 2011, explanted: (b)(6) 2018.Section 'device' information references the main component of the system.Other relevant device(s) are: product id: 8578, serial# (b)(4), ubd: 2013-01-29, udi# (b)(4).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 PUERTO RICO OPERATIONS CO.; road 31, km. 24, hm 4; ceiba norte industrial park; juncos PR 00777
• Manufacturer (Section G): MEDTRONIC PUERTO RICO OPERATIONS CO.; road 31, km. 24, hm 4; ceiba norte industrial park; juncos PR 00777
• Manufacturer Contact: lisa woodward clark ; 7000 central avenue ne rcw215; minneapolis, MN 55432 ; 7635263920
• MDR Report Key: 8065726
• MDR Text Key: 127057903
• Report Number: 3004209178-2018-25345
• Device Sequence Number: 1
• Product Code: LKK
• UDI-Device Identifier: 00643169630512
• UDI-Public: 00643169630512
• 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,Followup
• Report Date: 12/17/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/13/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 02/28/2020
• Device Model Number: 8637-40
• Device Catalogue Number: 8637-40
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/13/2018
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 12/17/2018
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 08/28/2018
• 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: 52 YR