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

Model Number 8637-40

Device Problems Inadequacy of Device Shape and/or Size (1583); Insufficient Information (3190)

Patient Problems Bruise/Contusion (1754); Pain (1994); Pocket Erosion (2013); Scar Tissue (2060)

Event Date 10/01/2019

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 consumer regarding a patient receiving sufentanil (500 mcg/ml at 29 mcg/day) via an implanted pump.The indication for pump use was non-malignant pain.On 03-feb-2020 the patient reported that in the middle of (b)(6) 2019 her pump started beeping every hour.She was hearing a single-toned alarm every hour and was wondering how to stop the alarm.Per the patient, her hcp (healthcare professional) had her on 40 mg of oral dilaudid for her hips and knees/back because she was crippled.Additional information was received from a health care provider on 2020-feb-04.It was reported that the patient is non-compliant and not reliable.The hcp had not heard any alarms and the reservoir volume was as expected during the patient's recent visit.The hcp's notes indicated that they were unable to verify the patient's current cancer status after several months search and were therefore tapering her pump dose down before the device expires.They initially planned to taper 8 mcg every week but the patient was not compliant with the plan and "comes in whenever she wants." she was last seen over two months prior.Additional information was received from the consumer on 04-aug-2020 who reported that they were trying to arrange a company representative to meet them at an upcoming appointment for pump removal and have the pump alarm turned off.Per the patient the pump has not been working, it stopped working in early (b)(6) 2019 and should have lasted until (b)(6) 2020.The patient stated that it had the same beeping sound it had originally had when it started beeping in november every hour, it changed to every 10 minutes in (b)(6).The patient described the critical alarm.The patient also stated at the end of (b)(6) 2020 she fell and the pump got hit.It was bruised up and was trying to come out of their skin.The patient further stated that they went through chemo treatment a couple of years ago, the skin is dead and it would have to get cut out.The pump had literally grown into their skin under the patient¿s ribcage.It was literally black and blue and coming out of their stomach.The patient was scheduled for a pre-op appointment to have their pump removed and stated she will not get the pump replaced.The patient was weaning off of the very large dose of (300mg) of sufentenil.No further complications were reported regarding the event.

Manufacturer Narrative

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

Event Description

Additional information was received from a healthcare professional (hcp) who reported that they took the patient¿s pump and catheter out (date not provided).They did not manage the patient¿s pump.Per this hcp, there was no alarm and no malfunction.The pump was too large causing skin trouble/damage and pain.

• 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: david gustafson ; 7000 central avenue ne rcw215; minneapolis, MN 55432 ; 7635149628
• MDR Report Key: 10378076
• MDR Text Key: 202012495
• Report Number: 3004209178-2020-13625
• Device Sequence Number: 1
• Product Code: LKK
• 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,health professional
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date: 09/29/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/07/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 05/28/2014
• Device Model Number: 8637-40
• Device Catalogue Number: 8637-40
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 09/24/2020
• Date Device Manufactured: 12/03/2012
• 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: 53 YR