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

Model Number 8637-20

Device Problems Kinked (1339); Material Integrity Problem (2978)

Patient Problems Unspecified Infection (1930); Fluid Discharge (2686)

Event Date 10/17/2013

Event Type  Injury  

Manufacturer Narrative

Concomitant medical products: product id: 8780, serial# (b)(4), implanted: (b)(6) 2013, explanted: (b)(6) 2014, product type: catheter.If information is provided in the future, a supplemental report will be issued.

Event Description

Information was received from a consumer regarding a patient who was receiving dilaudid (unknown concentration and dose) via an implantable pump.Indication for use was non-malignant pain and chronic low back pain.The date of the event was (b)(6) 2013.It was reported the patient experienced an infection along the catheter track and it was associated with implant.The symptom was drainage.The catheter was kinked and cracked and was suspected right after implant.It was unknown if the infection was confirmed.The patient had a revision however this didn't resolve.The patient had another surgery to replace the catheter.The patient had back to back procedures and the incision site was being constantly opened up.Interventions were intravenous and oral antibiotics and total system explant.The patient had a stroke in 2005 and had difficulty remembering dates and order of events.The patient was not clear on the event as there was a family death that occurred during this time.The patient developed renal failure and developed rsd (reflex sympathetic dystrophy).No further complications were reported.

Manufacturer Narrative

The previous report the aware date was reported as 2018-03-06.The correct aware date was (b)(6) 2013.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: 7385363
• MDR Text Key: 103966707
• Report Number: 3004209178-2018-06110
• Device Sequence Number: 1
• Product Code: LKK
• UDI-Device Identifier: 00643169100831
• UDI-Public: 00643169100831
• 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: consumer
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 03/30/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/30/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 02/14/2015
• Device Model Number: 8637-20
• Device Catalogue Number: 8637-20
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 03/06/2018
• Date Device Manufactured: 08/19/2013
• 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: 49 YR