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

Model Number 8637-20

Device Problems Occlusion Within Device (1423); Aspiration Issue (2883); Material Integrity Problem (2978)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 02/20/2018

Event Type  Injury  

Manufacturer Narrative

The main component of the device system; the other relevant components include: product id: 8709, serial#: (b)(4), implanted: (b)(6) 2005, explanted: (b)(6) 2018, product type: catheter.If information is provided in the future, a supplemental report will be issued.

Event Description

Information was received from a healthcare professional (hcp) via a manufacturer's representative (rep) regarding a patient who was receiving morphine at an unknown dose and concentration via an implantable infusion pump for an unknown indication for use.It was reported that a dye study was done and it was found that the catheter had a break in it.The pump and catheter were fully replaced.It was reported that the issue was resolved.The patient's status at the time of the report was noted as "alive-no injury." no further complications were anticipated/reported.

Manufacturer Narrative

Section d references the main component of the device system; the other relevant components include: product id 8709 lot# serial# (b)(4) implanted: 2005 (b)(6) explanted: 2018 (b)(6) product type catheter: 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

Additional information was received from a manufacturer's representative.The patient was receiving 25.0 mg/ml morphine at 5.055 mg/day, 30.0 mg/ml bupivacaine at 6.066 mg/day, and 1.0 mg/ml clonidine at 0.2022 mg/day.No further complications were anticipated/reported.

Manufacturer Narrative

Analysis of the catheter (lot# j12016r13) found a broken catheter body.Analysis visual inspection identified a break in the catheter.The cross section of the catheter was elliptical near the break, which is consistent with it being compress.The catheter was returned in segments and found patent with no leaks.Analysis of the pump (sn; (b)(4)) found no anomalies.The previously reported conclusion code 11 no longer applies to this event.The codes has been updated to 22.Device codes were updated to include (b)(4).If information is provided in the future, a supplemental report will be issued.

Event Description

On 2018-feb-20, additional information was received from a manufacturer representative (rep).On 2018 (b)(6), during a normal early replacement indicator (eri) battery replacement (also reported as end of service (eos)).During a dye study, the hcp found that the catheter (lot # j12016r13) was not functioning properly so the hcp "needed to replace catheter as well".The catheter was found to have a break in it.It was also stated that the catheter was not patent and needed to be fully revised.While the hcp was attempting to replace the old catheter, the hcp had an issue with the catheter (sn; (b)(4)) going retrograde out of the needle (described as surgical intervention).The hcp pulled out catheter and asked for a new 8780.It was also noted that a revision catheter kit (lot# hg23y7k01) was opened and but never implanted due to discovery of the broken catheter.The patient did not express any symptoms prior to surgery.The issue was resolved at the time of this report.The patient's status was alive - no injury.

Manufacturer Narrative

Product id: 8709, serial# (b)(4), implanted: (b)(6) 2005, explanted: (b)(6) 2018, product type: catheter; product id: 8780, serial# (b)(4), product type: catheter; product id: 8578, lot# hg23y7k01, product type: catheter.Analysis found that damage was done to the catheter body/guidewire during th implant procedure.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: 7289025
• MDR Text Key: 100686415
• Report Number: 3004209178-2018-03762
• 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
• Report Date: 05/11/2018

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
• Device Operator: Health Professional
• Device Expiration Date: 01/14/2013
• Device Model Number: 8637-20
• Device Catalogue Number: 8637-20
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 03/06/2018
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 02/20/2018
• Initial Date FDA Received: 02/22/2018
• Supplement Dates Manufacturer Received: 03/02/2018; 02/20/2018; 04/30/2018
• Supplement Dates FDA Received: 03/07/2018; 03/20/2018; 05/11/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 07/19/2011
• 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: 50 YR