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

Model Number 8637-20

Device Problems Filling Problem (1233); Off-Label Use (1494); Activation Failure (3270)

Patient Problem No Known Impact Or Consequence To Patient (2692)

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 health care professional (hcp) via a representative regarding a patient in (b)(6) who received bupivacaine 50 mg/ml at a dose of 10.001 mg/day and clonidine 50 mg/ml at a dose of 10.001 mg/day via an implantable pump.The indication for use was not provided.It was reported that during a refill procedure on (b)(6) 2018, the physician ¿was able to suck with difficult the reservoir but could not inject only 7ml on the 20ml envisaged¿.The physician did the filling under fluoroscopy.As reported, the pump¿s bellows were not expanding per x-ray image.A provided image of the pump was consistent with this report.For now, there were no symptoms or effects for the patient.The estimated replacement indicator (eri) was 25 months.Actions/interventions included the physician controlling the pump at fluoroscopy.Additional information was received from a foreign hcp via a manufacturing representative.It was further reported that this was not the first time the physician experienced aspiration and filling difficulties with this pump; this was the third time with one refill per month.The healthcare provider (hcp) did not use a refill kit from the pump manufacturer.A 0.7x50 needle from a different device manufacturer was used.At the (b)(6) 2018 refill, 1.5 cc was left in the pump, and only 7 cc could be injected (against very high resistance).It was clarified that the previously reported statement ¿could not inject only 7 ml on the 20 ml envisaged¿ was in reference to the physician only being able to fill the pump with 7 ml.The pump was defective and would be replaced on (b)(6) 2018; at this time, the reservoir would probably be empty.At the time of the report, the issue was not resolved and the patient¿s status was reported as alive, no injury.At this time, the pump remained implanted and in-service.There were no [additional] environmental, external or patient factors reported that might have led or contributed to the event.The patient¿s weight was unknown.There were no further complications 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 event was not determined.It was reported that the pump will be explanted this afternoon on (b)(6) 2018.No further complications were reported and/or anticipated.

Manufacturer Narrative

Analysis of the pump found fluid path reservoir access issue due to residue before internal decontamination.(b)(4).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: 7268588
• MDR Text Key: 99980835
• Report Number: 3004209178-2018-03252
• 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: Other
• Type of Report: Initial,Followup,Followup
• Report Date: 03/28/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/13/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 10/14/2014
• Device Model Number: 8637-20
• Device Catalogue Number: 8637-20
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/23/2018
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 03/22/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 04/15/2013
• 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
• Patient Outcome(s): Required Intervention