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

Model Number 8637-40

Device Problems Disconnection (1171); Migration or Expulsion of Device (1395); Occlusion Within Device (1423); Inadequacy of Device Shape and/or Size (1583); Device Operates Differently Than Expected (2913); Difficult to Advance (2920)

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

Event Date 03/23/2012

Event Type  Injury  

Manufacturer Narrative

Information references the main component of the system and other applicable components are: product id: 8709sc, serial# (b)(4), implanted: (b)(6) 2012, explanted: (b)(6) 2012, product type: catheter.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

Information was received from a patient who was receiving morphine (unknown dose and concentration) via an implantable pump for non- malignant pain.The patient looked up issues with his symptoms and discovered there were recalls, the patient had problems with every pump stating that no matter what doctor you tell about the issue they don't want to believe you.They did the surgery on (b)(6) 2012 and put in the wrong size, shortly after that surgery on (b)(6) 2012 patient started having serious pain problems and started reporting it before the pump size that he was having so much pain and felt that he could feel the catheter moving and he could touch it and move it around, the catheter became disconnected and wasn't working.The pump was replaced on (b)(6) 2012 because it was the wrong size, the healthcare professional woke patient up after the pump surgery replacement and the patient inquired about the catheter and the catheter was not looked at during the operation so patient was put back under and they looked at the catheter.When they did the surgery it was found that the catheter became disconnected; the catheter was plugged (blocked) bad and they had never seen anything (blockage) like that, the health care professional stated that they must have had trouble threading the catheter.

Manufacturer Narrative

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: 6610653
• MDR Text Key: 76638101
• Report Number: 3004209178-2017-11581
• 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: consumer
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 06/05/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/05/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 07/28/2013
• Device Model Number: 8637-40
• Device Catalogue Number: 8637-40
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 05/31/2017
• Date Device Manufactured: 02/08/2012
• 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: 63 YR