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

Model Number 8637-20

Device Problems Overfill (2404); Activation Failure (3270)

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

Event Date 02/27/2018

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) regarding a patient receiving 1 mg/ml of dilaudid at 0.2199 mg/day via an implantable pump for non-malignant pain.It was reported that on (b)(6) 2018 the patient¿s pump was refilled, and the hcp was able to aspirate, but unable to completely fill the pump.The hcp aspirated everything they expected to aspirate and had pulled back during the refill process.The hcp reported they were only able to get 30 mls into the pump.The locked valve procedure (holding negative pressure) was reviewed.The hcp indicated they would call back at the next refill if they continued to have issues.No symptoms were reported.No further complications were reported or anticipated.

Manufacturer Narrative

Review of this mdr and additional information received shows that there is no information to reasonably suggest that the device in this report may have caused or contributed to a death or serious injury or that the device in this report has malfunctioned.Therefore, this event did not and does not meet the reporting requirements stipulated in 21 cfr 803.Device code (b)(4) has been changed to (b)(4).If information is provided in the future, a supplemental report will be issued.

Event Description

Additional information was received from the healthcare provider (hcp) on march 09, 2018.The healthcare provider verified that the pump model and serial number included in this event was correct, and therefore verified the patient did have a 20 ml pump implanted.In regards to the question,"please verify the reason for the revision in 6-12 months.Is it specifically related to this device issue, or a different reason (please specify)?" the healthcare provider responded, "we did not revise the system.".

Manufacturer Narrative

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

Event Description

Additional information was received from the healthcare provider (hcp) on march 02, 2018.Regarding troubleshooting performed to determine the cause of the difficulty filling the pump; the hcp verified the position of the needle, aspirated all volume and air, and verified the pump size.The hcp indicated it had not been determined why they were unable to fill more than 30 mls on (b)(6) 2018.(of note, per the manufacture's device registry the pump implanted in the patient only has a reservoir volume of 20 mls).Regarding actions and interventions taken or planned, the hcp filled the pump with 30 mls and planned to refill the pump sooner.The hcp also stated, "will likely need revision within next 6-12 months.".

• 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: 7307773
• MDR Text Key: 101487527
• Report Number: 3004209178-2018-04273
• 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: health professional
• Reporter Occupation: Nurse
• Type of Report: Initial,Followup,Followup
• Report Date: 03/13/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/01/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 02/14/2015
• Device Model Number: 8637-20
• Device Catalogue Number: 8637-20
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 03/09/2018
• Date Device Manufactured: 08/27/2013
• 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
• Patient Age: 39 YR
• Patient Weight: 105