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

Model Number 8637-20

Device Problem Occlusion Within Device (1423)

Patient Problems Pain (1994); Underdose (2542)

Event Date 02/01/2018

Event Type  Injury  

Manufacturer Narrative

Other applicable components are: product id: 8709sc, lot# b0851684k, implanted: (b)(6) 2008, product type: catheter.(b)(6).If information is provided in the future, a supplemental report will be issued.

Event Description

Information was received from a foreign healthcare professional (hcp) via a manufacturer representative regarding a patient who was receiving dilaudid 2000 mygr/ml at 1000 mygr/day via an implantable pump for an unknown indication for use.It was reported that the patient came to the pain unit with more pain and underdose symptoms.During a sideport test it was noted that it became obvious that the catheter is blocked.It was noted that neither aspiration ¿nor apply some fluid¿ was possible.It was noted that a rotor test was completed and no issues were seen.It was reported that a partial explanted of the catheter was performed and that approximately 15 cm of the catheter is still implanted in the patient¿s lateral abdominal/flank.It was reported that the issue was resolved at the time of the report.The patient status at the time of the report was alive-no injury.There was no history of volume discrepancies.The partial catheter would be returned.There were no known environmental/external/patient factors that may have led or contributed to the issue.No further complications were reported and/or anticipated.

Manufacturer Narrative

Analysis of the catheter, model# 8709sc, lot# b0851684k , found a circular tear and/or coring into the sealing surface of the sutureless connector cup.A leak was observed during pressure testing.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): MEDTRONIC PUERTO RICO OPERATIONS CO.; road 31, km. 24, hm 4; ceiba norte industrial park; juncos PR 00777
• Manufacturer (Section G): MEDTRONIC PUERTO RICO OPERATIONS CO.; road 31, km. 24, hm 4; ceiba norte industrial park; juncos PR 00777
• Manufacturer Contact: lisa woodward clark ; 7000 central avenue ne rcw215; minneapolis, MN 55432 ; 7635263920
• MDR Report Key: 7267835
• MDR Text Key: 99951911
• Report Number: 3004209178-2018-03230
• Device Sequence Number: 1
• Product Code: LKK
• Combination Product (y/n): N
• Reporter Country Code: SZ
• PMA/PMN Number: P860004
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 03/19/2018

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: 12/28/2016
• Device Model Number: 8637-20
• Device Catalogue Number: 8637-20
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 02/01/2018
• Initial Date FDA Received: 02/13/2018
• Supplement Dates Manufacturer Received: 03/07/2018
• Supplement Dates FDA Received: 03/19/2018
• Date Device Manufactured: 07/10/2015
• 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
• Patient Weight: 90