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); Volume Accuracy Problem (1675); Aspiration Issue (2883)

Patient Problems Diarrhea (1811); Nausea (1970); Vomiting (2144); Malaise (2359)

Event Date 03/14/2018

Event Type  Injury  

Manufacturer Narrative

Information references the main component of the system.Other relevant device(s) are: product id: 8709sc, serial/lot #: (b)(4), ubd: 10-nov-2009, udi#: (b)(4).If information is provided in the future, a supplemental report will be issued.

Event Description

Information was received from a device manufacturer representative regarding a patient who was receiving hydromorphone (10 mg/ml at minimum rate), bupivacaine (22 mg/ml at minimum rate), and baclofen (29 mcg/ml at minimum rate) via an implantable infusion pump for non-malignant pain and failed back surgery syndrome.It was reported that about one week prior to (b)(6) 2018, the patient started having flu-like symptoms, including nausea, vomiting, and diarrhea.The patient was seen for a routine refill on (b)(6) 2018 and the healthcare provider (hcp) got back significantly more than expected.The patient was refilled on (b)(6) 2018 and the pump was turned down to minimum rate.The patient was given oral dilaudid and morphine, and was only taking oral dilaudid, but had not taken more.The actual residual volume (arv) was greater than the expected residual volume (erv).The volume discrepancy was reported, but volumes were unknown.The patient was due for a catheter revision on (b)(6) 2018 and was going to be monitored after the case for 23 hours postoperatively.No further complications were reported.

Manufacturer Narrative

Other applicable components are: product id: 8709sc, serial# (b)(4), implanted: (b)(6) 2007, product type: catheter.If information is provided in the future, a supplemental report will be issued.

Event Description

Additional information was received from a consumer via a device manufacturer representative.It was reported that the actual and expected residual volumes were unknown.The cause of the volume discrepancy was noted to be an inability to aspirate the catheter.The volume discrepancy resolved.A small segment of the catheter was removed and thrown away by the scrub.No further complications were reported.

Manufacturer Narrative

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

Event Description

Additional information was received.It was reported that the cause of the inability to aspirate the catheter was not determined.

Manufacturer Narrative

Pt's sex was changed to "unknown" due to conflicting information from the manufacturer's records and the business partner's report.If information is provided in the future, a supplemental report will be issued.

Event Description

Additional information was received.It was reported that on (b)(6) 2018, the catheter was found to be occluded.On (b)(6) 2018, the patient was admitted to the hospital for an occluded intrathecal catheter and chronic pancreatitis (not further specified).The patient's gender was set to unknown due to contradictory information.The manufacturer's records regarding that patient's sex differ from the business partner's report.No further complications were reported.

• 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: 7371062
• MDR Text Key: 103515555
• Report Number: 3004209178-2018-05744
• 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,consum
• Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup,Followup
• Report Date: 04/20/2018

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: 04/28/2014
• Device Model Number: 8637-20
• Device Catalogue Number: 8637-20
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 03/23/2018
• Initial Date FDA Received: 03/26/2018
• Supplement Dates Manufacturer Received: 04/10/2018; 04/11/2018; 04/18/2018
• Supplement Dates FDA Received: 04/11/2018; 04/12/2018; 04/20/2018
• Date Device Manufactured: 11/13/2012
• 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): Hospitalization; Required Intervention
• Patient Age: 54 YR
• Patient Weight: 72