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); Device Operates Differently Than Expected (2913)

Patient Problems Pain (1994); Complaint, Ill-Defined (2331)

Event Date 12/20/2017

Event Type  Injury  

Manufacturer Narrative

Concomitant medical products: product id: 8711, serial#: (b)(4), implanted: (b)(6) 2011, explanted: (b)(6) 2018, product type: catheter.The main component of the system; other relevant device(s) are: product id: 8711, serial/lot #: (b)(4), ubd: 02-feb-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 professional (hcp) via manufacturer representative (rep) regarding a patient who was receiving an unknown drug at an unknown concentration and dose via intrathecal drug delivery pump for non-malignant pain and failed back syndrome - other.It was reported that the patient had increased pain and failed "cds." there were no known environmental, external or patient factors that may have led or contributed to the issue.The catheter was checked in surgery and it was sluggish (most likely referring to the flow of cerebrospinal fluid); they tried to revise the catheter but it continued to be sluggish, so the hcp replaced the pump and the catheter with an 8781 catheter.The explanted catheter would be returned and was in the possession of the rep.The issue was resolved and the patient status was "alive - no injury" at the time of this report.No further complications were reported.

Manufacturer Narrative

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

Event Description

Pump logs indicated that the patient was receiving clonidine (2000.0 mcg/ml, 96.0 mcg/day) and bupivacaine (11.5 mg/ml, 0.552 mg/day).

Manufacturer Narrative

Continuation of concomitant medical products: product id: 8711, serial# (b)(4), implanted: (b)(6) 2011, explanted: (b)(6) 2018, (b)(4), product type: catheter; product id 8709, lot# l78693, upn: (b)(4), 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.(b)(4).If information is provided in the future, a supplemental report will be issued.

Event Description

Additional information received from healthcare professional (hcp) via a clinical study indicated the patient was receiving clonidine 2000 mcg/ml for a total dose of 352.3 mcg/day and bupivacaine 11.5 mg/ml for a total dose of 2.026 mg/day.It was noted that the patient has a intrathecal pump with an increase in pain therefore a catheter dye study was to be performed.The catheter assess port study was scheduled and performed on (b)(6) 2017.It was stated that the catheter access port could not be aspirated.The patient had a failed catheter dye study.The entire system was explanted/replaced on (b)(6) 2018 and was returned to manufacturer.The device diagnosis was catheter occlusion and the clinical diagnosis was increase in pain.The outcome of the event resolved without sequelae on (b)(6) 2018.The etiology of the event indicated the relationship of the event to the device or therapy was related and indicated the relationship of the event to the implant procedure was not related.No further complications were reported/anticipated.

Manufacturer Narrative

Product id 8711 (b)(4) implanted: (b)(6)2011 explanted: (b)(6)2018 product type catheter (b)(4) product id 8709, lot# l78693, implanted: explanted: product type catheter.Udi (b)(4)catheter (b)(4) product id 8711.The catheter was returned, and analysis found no significant anomaly.Catheter lot number l78693 product id 8709.The catheter was returned, and analysis found an anomaly of the non-sutureless connect (sc) pump connector.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: 7349814
• MDR Text Key: 102787530
• Report Number: 3004209178-2018-05297
• 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: 03/28/2013
• Device Model Number: 8637-20
• Device Catalogue Number: 8637-20
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 03/20/2018
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 03/15/2018
• Initial Date FDA Received: 03/19/2018
• Supplement Dates Manufacturer Received: 03/15/2018; 03/19/2018; 04/19/2018
• Supplement Dates FDA Received: 03/19/2018; 04/04/2018; 05/11/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 10/12/2011
• 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: 73 YR
• Patient Weight: 80