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

Model Number 8637-20

Device Problems Excess Flow or Over-Infusion (1311); Volume Accuracy Problem (1675)

Patient Problem Therapeutic Response, Decreased (2271)

Event Type  Injury  

Manufacturer Narrative

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

Event Description

Information was received from a healthcare provider (hcp) via a manufacturer representative regarding a patient who was receiving di laudid (11.5mg/ml at 2mg/day) via intrathecal drug delivery pump.The indication for use was not noted.It was reported that the pump did not seem to reduce the patient's pain as it had previously.There was less volume than expected at the time of the last refill.A catheter dye study had been obtained and the catheter was considered patent.The physician elected to remove and replace the pump early, on (b)(6) 2018, due to the volume discrepancy and the patient self-reporting.At the time of the removal of the pump, the scrub nurse attempted to remove the expected 13.2ml of drug.She was unable to remove any fluid from the reservoir.It was unknown if the issue was resolved.The patient was reported as "alive - no injury." there were no further complications reported at this time.

Manufacturer Narrative

Analysis results were not available at the time of this report.A follow-up report will be sent when analysis is completed.If information is provided in the future, a supplemental report will be issued.

Event Description

Additional information was received from the manufacturer representative.The pump was delivering dilaudid at 2.459mg/day, per interrogation logs.There were no further complications reported at this time.

Manufacturer Narrative

Analysis of the implantable pump (serial # (b)(4)) identified no anomalies.The returned device passed all functional testing in the laboratory.If information is provided in the future, a supplemental report will be issued.

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: 7611373
• MDR Text Key: 111395578
• Report Number: 3004209178-2018-13696
• 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
• Remedial Action: Recall
• Type of Report: Initial,Followup,Followup,Followup
• Report Date: 10/04/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/18/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 03/28/2014
• Device Model Number: 8637-20
• Device Catalogue Number: 8637-20
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/20/2018
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 08/08/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 09/28/2012
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Removal/Correction Number: Z-1570-2014
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention