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

Model Number 8637-20

Device Problems Break (1069); Material Integrity Problem (2978); Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Therapeutic Effects, Unexpected (2099); Discomfort (2330); Complaint, Ill-Defined (2331); No Code Available (3191)

Event Date 01/01/2017

Event Type  Injury  

Manufacturer Narrative

Concomitant medical products: product id: 8709sc, serial#: (b)(4), implanted: (b)(6) 2011, explanted: (b)(6) 2018, product type: catheter.Other relevant device(s) are: product id: 8709sc, serial/lot #: (b)(4), ubd: 20-sep-2013, udi#: (b)(4).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 company representative regarding a patient who was receiving compounded baclofen with concentration 1200.0 mcg/ml at a dose rate of 155 mcg/day and morphine with concentration 15.0 mg/ml at a dose rate of 1.938 mg/day via an implantable pump for intractable spasticity and multiple sclerosis.The drug lot number of compounded baclofen and morphine were unable to be obtained.It was reported that the patient was originally scheduled for a pump replacement.The patient had requested a change in the pump location which led to the physician deciding to replace the original catheter as well.The patient told them on (b)(6) 2018, prior to the replacement pump surgery, that she believed her pump system had not been providing adequate relief for the last year.The date (b)(6) 2017 is considered an approximate date of event (year known only).The event occurred during normal use.It was further clarified that during the pump replacement, the surgeon chose to replace the entire catheter.While removing the old catheter, they were able to identify a break in the catheter.The spinal segment of catheter was broken at the connection point, underneath the clear sleeve.The catheter was removed completely and replaced with another catheter of an alternate model.Regarding environmental/external/patient factors that may have led or contributed to the issue, it was noted there were no known issues.The pump and complete catheter was explanted.The explanted devices were planned to be returned to the manufacturer.The issue was resolved at the time of the report.The patient was without injury regarding their status at the time of the report.The patient¿s medical history and weight were indicated as having been requested but were unknown.Other medications (oral, etc.) the patient was receiving at the time of the event was unable to be obtained.It was noted that the morphine dose was decreased to 0.968 mg/day and compounded baclofen was decreased to 77.5 mcg/day to prevent possible overdose.No further patient complications have been reported as a result of this event.

Manufacturer Narrative

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

Event Description

Additional information was received from a company representative.It was clarified that regarding the patient¿s pump, end of service (eos) had not yet occurred but was anticipated.The pump was replaced as part of normal maintenance.The eos was considered normal.It was noted that the information provided was confirmed with the physician/account.

Manufacturer Narrative

H3: only the catheter was returned for analysis.Analysis of the catheter on 2018-oct-18 revealed a broken catheter body and also a user related issue regarding dark residue occlusion in the dispensing holes of the catheter body.Analysis noted dark material deposited in the most proximal of the dispensing holes prior to decontamination.H6 update: the conclusion code 67 is no longer applicable.The previously applied method code 4114 and results code 3221 remain app licable to the pump.The conclusion code 22 is applicable to the pump.The method code 10 applies to the catheter.The results code 114 and conclusion code 19 regarding the catheter pertains to the analysis finding of dark residue occlusion in the dispensing holes of the catheter body.The results code 180 and conclusion code 22 regarding the catheter pertains to the analysis finding regarding broken catheter body.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.

Manufacturer Narrative

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

Event Description

Additional information was received via a company representative.Regarding the patient having requested a change in pump location, it was clarified that there was no device issue.The patient was experiencing discomfort where the original pump was located.It was noted that the patient did not specify a date when she began to experience discomfort with the pump location.The pump was relocated.Regarding the reason for the pump having been replaced, end of service was indicated.The affected pump was disposed of at the hospital and was not planned on being returned with the catheter.

Manufacturer Narrative

Update: the previously applied patient code (b)(4) is no longer applicable.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: 7739451
• MDR Text Key: 115700651
• Report Number: 3004209178-2018-17146
• 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,Followup,Followup,Followup
• Report Date: 10/19/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/01/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 04/14/2013
• Device Model Number: 8637-20
• Device Catalogue Number: 8637-20
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/15/2018
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 10/18/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 10/25/2011
• 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: 56 YR