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); Aspiration Issue (2883)

Patient Problem Therapeutic Response, Decreased (2271)

Event Date 11/29/2017

Event Type  Injury  

Manufacturer Narrative

Information references the main component of the system and other applicable components are: product id neu_unknown_cath, product type catheter.Product id 8731sc, serial# (b)(4), implanted: (b)(6) 2011, explanted: (b)(6) 2017, product type catheter.Analysis results were not available as of the date of this report.A follow-up report will be submitted when analysis is complete.

Event Description

Information was provided by a healthcare provider and a consumer via a manufacturer¿s representative regarding an implantable intrathecal pump intended to deliver morphine [15.0 mg/ml] at 1.708 mg/day, indicated for non-malignant pain.It was reported that the patient had been having a loss of therapy for a couple of weeks prior to (b)(6) 2017.It was noted that this was considered a sudden change in therapy/symptoms.It was reported that the patient had previously reported to the hcp that she was having withdrawal symptoms.On the day of surgery, the rep was told by both the patient and the physician that "the pump wasn't working." it was reported that the patient didn¿t feel she was receiving therapy, and the hcp assumed it was the pump.It was noted that since the pump was near eri (elective replacement indicator), the physician decided to replace it on (b)(6) 2017.During the case, the rep recommended the hcp check the catheter.It was reported that the hcp was unable to aspirate at any point in the catheter.It was confirmed during the procedure that the catheter was occluded.The physician replaced the entire system.Additional information was received from a manufacturer's representative on (b)(6) 2017.The pump and catheter were returned for analysis.The logs returned with the device indicate that the pump indicate that the estimated eri was at 7 months.No further complications were reported/anticipated.

Manufacturer Narrative

Analysis of the sc catheter (pli 20) found that there was a non-significant indent in the seal of the sc connector and it did not affect infusion.Analysis of the unknown catheter (pli 30) found that there was a dark residue occlusion in the dispensing holes.If information is provided in the future, a supplemental report will be issued.

Manufacturer Narrative

Updated to reflect the patient's weight received on (b)(6) 2018.If information is provided in the future, a supplemental report will be issued.

Event Description

Additional information was received from the patient's healthcare provider (hcp) on (b)(6) 2018.The patient's weight was provided.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 from the hcp on 2018-feb-20.When asked about the status of the catheter, the hcp stated that "it was cut in pieces as it was being assessed.When the decision was made to replace it, i could not pull it all out from the adipose tissue.Some was left behind.I'm not sure if the pieces were sent to you or not." there were no further complications reported/anticipated.

• 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: 7173552
• MDR Text Key: 96695825
• Report Number: 3004209178-2018-00419
• 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: Physician
• Type of Report: Initial,Followup,Followup,Followup
• Report Date: 02/22/2018

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: 02/14/2013
• Device Model Number: 8637-20
• Device Catalogue Number: 8637-20
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/04/2018
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 12/13/2017
• Initial Date FDA Received: 01/08/2018
• Supplement Dates Manufacturer Received: 01/09/2018; 02/01/2018; 02/20/2018
• Supplement Dates FDA Received: 01/10/2018; 02/05/2018; 02/22/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 08/26/2011
• 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: 47 YR
• Patient Weight: 83