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

Model Number 8637-40

Device Problems Difficult to Interrogate (1331); Migration or Expulsion of Device (1395); Unstable (1667)

Patient Problems Pain (1994); Therapeutic Response, Decreased (2271); Discomfort (2330); Complaint, Ill-Defined (2331)

Event Date 01/01/2015

Event Type  malfunction  

Event Description

On (b)(6) 2016, information was received from a consumer regarding a (b)(6), female patient who was receiving dilaudid (concentration unknown) at "2 point something" via an implantable pump for malignant (bone) pain.On an unknown date in 2015, the patient's pump moved a lot during refills.They had to hold down the pump during refills.The movement started six months prior to (b)(6) 2016 and got worse about 3 months ago.The pump was close to flipping and the personal therapy manager (ptm) would not connect.The patient had to wear spanks to hold the pump in as it was floating around.If the patient moved right, she could feel the pump sutures move and tug.The patient was working with a surgeon to discuss a revision, but she needed tests first.

Manufacturer Narrative

Concomitant medical products: product id 8709sc, serial# (b)(4), implanted: (b)(6) 2012, product type: catheter.A good faith effort will be made to obtain the applicable information relevant to the report.If information is provided in the future, a supplemental report will be issued.

Event Description

Additional information was received from a healthcare professional on 25-aug-2016 and it was reported that the patient had tenderness at the pump site as her pump moved a lot.Additional information was received on 26-aug-2016 from a consumer and it was reported that the patient had an upcoming appointment for a dye study in the next week or so.The patient had lost a lot of weight and the hcp (healthcare professional) was thinking the pump movement had now caused the catheter to drop down.The dye study was to assess if this had actually happened.They wanted the patient to finish losing the last 10 pounds or so and then they would fix the pump when she had them remove her ¿extra skin¿.The patient was having a change in therapy/return of pain which had occurred gradually.

Manufacturer Narrative

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

Event Description

Additional information was received and it was reported that the patient¿s pump has been moving since the patient started losing weight.The patient had to wear spanks to hold it in place.The pump can be physically moved and it does not stay in place.The patient was getting no pain relief from the pump.The patient had contacted the healthcare provider who told the patient to contact the manufacturer.The patient has had no falls or traumas and was not hearing alarms from the pump.No further complications were reported.

Manufacturer Narrative

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: 5644458
• MDR Text Key: 44893185
• Report Number: 3004209178-2016-09202
• 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: Other
• Type of Report: Initial,Followup,Followup,Followup
• Report Date: 01/17/2018

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: 09/28/2013
• Device Model Number: 8637-40
• Device Catalogue Number: 8637-40
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 04/19/2016
• Initial Date FDA Received: 05/10/2016
• Supplement Dates Manufacturer Received: Not provided; 08/25/2016; 01/16/2018
• Supplement Dates FDA Received: 09/20/2016; 09/22/2017; 01/17/2018
• Date Device Manufactured: 04/09/2012
• 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 Age: 33 YR