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

Model Number 8637-20

Device Problems Insufficient Flow or Under Infusion (2182); Appropriate Term/Code Not Available (3191)

Patient Problems Abdominal Pain (1685); Pain (1994); No Known Impact Or Consequence To Patient (2692)

Event Type  malfunction  

Manufacturer Narrative

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

Event Description

Information was received from a consumer regarding a patient who was receiving unknown drug, unknown concentration at unknown dose via intrathecal drug delivery pump for non-malignant pain and chronic low back pain.It was reported that patient would like to have pump taken out.The consumer thought pump did not work and had no medication in it.The consumer stated she did not know if there was a problem with the pump.No out of box failure was reported.No medical/therapy problem related to a small components product was reported.Patient became a resident (b)(6) 2017 and prior to that there was nothing in the pump.No symptom was reported.No further complications were reported.

Manufacturer Narrative

(b)(4).If information is provided in the future, a supplemental report will be issued.

Event Description

Additional information was received from a healthcare provider (hcp).It was reported that the resident no longer used the pain pump and wanted it removed because it caused him pain.The empty pump had not been resolved and was still in place.There were no further complications reported at this time.

Manufacturer Narrative

Correction to include adverse event in addition to the product problem.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.

Manufacturer Narrative

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

Manufacturer Narrative

Event description: updated to reflect the information received on 2019-mar-22; (b)(4) added to reflect the updated information received on 2019-mar-22.If information is provided in the future, a supplemental report will be issued.

Event Description

Additional information was received from a healthcare provider (hcp) on 2019-mar-22.It was reported that the patient was again experiencing pain in their abdominal area because the patient is thin.The patient had reportedly started experiencing the pain in (b)(6) 2018, but stopped complaining about it until about (b)(6) 2019.The hcp noted that the patient had been weaned of off their pump a while ago, though not because of any pump/therapy issues.The pump contained saline in the pump at the time of the event.The patient was requesting physician listings to find an hcp to remove their pump.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: 7726395
• MDR Text Key: 115416669
• Report Number: 3004209178-2018-16813
• Device Sequence Number: 1
• Product Code: LKK
• UDI-Device Identifier: 00643169100831
• UDI-Public: 00643169100831
• 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,Followup,Followup,Followup
• Report Date: 03/28/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/27/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 05/14/2015
• Device Model Number: 8637-20
• Device Catalogue Number: 8637-20
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 03/22/2019
• Date Device Manufactured: 11/15/2013
• 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