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

Model Number 8637-40

Device Problem Volume Accuracy Problem (1675)

Patient Problems Fall (1848); Overdose (1988); Blurred Vision (2137); Dizziness (2194); Reaction (2414); No Known Impact Or Consequence To Patient (2692)

Event Date 12/01/2016

Event Type  Injury  

Event Description

Information was received from a company representative regarding a patient currently receiving dilaudid and bupivacaine dose and co ncentration not reported via an implantable pump.The pump had previously been delivering fentanyl, bupivacaine and dilaudid dose and concentration not reported.The indications for use were non-malignant pain and degenerative disc disease.The patient reported a volume discrepancy.Per the patient the last 3 times they were refilled there was a suspicion there was more medication then expected at refill time.The patient was scheduled for a catheter dye study on (b)(6) 2017.The patient stated that they were refilled about every 6 weeks.The patient was wondering if a company representative could be paged to be at their next refill date (b)(6) 2017 and also the patient¿s upcoming catheter dye study.There were no patient symptoms reported.

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

Additional information was received by a consumer on 27-mar-2017.It was reported that the volume discrepancies varied.There was no noticeable cause in the patient's volume changes other than a physical reaction.A dye study was done on (b)(6) 2017.There was no noticeable evidence of abnormal catheter function.It was noted that the patient had an apparent change in physiological reaction with no obvious mechanical cause.A new pain pump was implanted, which replaced the older unit.Replacing the unit was anticipated to resolve the issue.No further patient complications were reported.

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

Additional information was received from a healthcare provider (hcp) and a device manufacturer representative (rep).The patient was consistently having 6-8 ml of reservoir discrepancies at refills for the past year.No environmental, external, or patient factors were noted to have led or contributed to the issue.The pump was replaced on (b)(6) 2017.The issue was resolved and the patient was noted to be "alive-no injury".The patient was receiving 20 mg/ml dilaudid at 12.5 mg/day and 20 mg/ml bupivacaine at 12.5 mg/day.No further complications were reported or anticipated.

Manufacturer Narrative

Analysis results were not available at the time of this report.A follow-up report will be sent when analysis is completed.(b)(4).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 pump was returned for analysis.

Manufacturer Narrative

The pump was returned for analysis.The pump logs indicated that the pump had been used to deliver dilaudid (20 mg/ml at 12.538 mg/day) and bupivacaine (20 mg/ml at 12.538 mg/day).Pump analysis found gear train anomalies of a stall due to shaft bearing and corrosion, wear or lubrication.(b)(4).If information is provided in the future, a supplemental report will be issued.

Manufacturer Narrative

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

Manufacturer Narrative

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

Manufacturer Narrative

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

Event Description

Additional information was received from a consumer indicated there was a high concern in the implant device¿s function.It was noted the previous reported discrepancies consisted of unreliable over doses resulting in dizziness, blurred vision, and numerous falls.There was no change in the malfunctioning device ¿i.E.Same physiological reactions, total unreliability.¿ it was noted the patient¿s volume discrepancies had been resolved.Steps taken to resolve the volume discrepancies were intrathecal implant pump replacement, post two month wait.No further complications were reported/anticipated or expected.

• 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: 6365405
• MDR Text Key: 68598776
• Report Number: 3004209178-2017-04758
• 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: company representative,consum
• Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup,Followup,Followup
• Report Date: 10/24/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/28/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 04/28/2013
• Device Model Number: 8637-40
• Device Catalogue Number: 8637-40
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/11/2017
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 10/10/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 11/03/2011
• 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): Required Intervention
• Patient Age: 66 YR