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

Model Number 8637-40

Device Problems Material Too Rigid or Stiff (1544); Unstable (1667); Improper or Incorrect Procedure or Method (2017); Device Displays Incorrect Message (2591); Device Operates Differently Than Expected (2913); Material Integrity Problem (2978)

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

Event Date 07/01/2017

Event Type  Injury  

Manufacturer Narrative

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

Manufacturer Narrative

Analysis results were not available at the time of this report. A follow-up report will be sent when analysis is completed. Conclusion code ¿ is being updated regarding the pump and catheter for this event. If information is provided in the future, a supplemental report will be issued.

Event Description

Additional information was received from a company representative (rep) indicated the pump and catheter were sent to the manufacturer to be analyzed. It was reported the reason the doctor wanted it analyzed was that they noted the catheter seemed to be fragile and it seemed like the catheter had hardened over time. No further complications were reported/anticipated or expected.

Manufacturer Narrative

The other relevant component includes: product id 8731 (b)(4) implanted: (b)(6)2006 explanted: (b)(6)2017 product type catheter. Evaluation of implantable pump (b)(4) did not reveal any anomalies. The returned pump passed all functional testing in the lab. Evaluation of implantable catheter (b)(4) revealed multiple user related holes in the body of the catheter, and identified a compressed region on the body of the catheter. If information is provided in the future, a supplemental report will be issued.

Manufacturer Narrative

The main component of the device system; the other relevant components include: product id: 8731, serial# (b)(4), implanted: (b)(6) 2006, 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

Information was received from a healthcare provider (hcp) regarding a patient who was receiving 5000 mcg/ml fentanyl at a dose of 2500 mcg/day via an implantable infusion pump for malignant pain, degenerative disc disease/herniated disc pain, and spinal pain. It was suspected that the patient had a flipped pump. The hcp suspected it was flipped due to refill troubles they have had. It was reported that the hcp may have missed the port and injected the drug subcutaneously when refilling. The patient ended up in intensive care for 3-5 days. No specific symptoms were mentioned. The hcp reported that the pump was empty and they may try to manually flip the pump and fill it with saline until the patient can see the surgeon. It was reported the patient had a ct scan that made the hcp think that the catheter may be cut off or fragmented. It was reported the ct scan was done about two weeks prior to (b)(6) 2017. No further complications were anticipated/reported.

• 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: 6750178
• MDR Text Key: 100188513
• Report Number: 3004209178-2017-15767
• 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: company representative,health

Reporter Occupation

• Remedial Action: Recall
• Type of Report: Initial,Followup,Followup,Followup
• Report Date: 10/30/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/28/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes

Device Operator

• Device Expiration Date: 02/28/2014
• Device Model Number: 8637-40
• Device Catalogue Number: 8637-40
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/11/2017
• Is the Reporter a Health Professional?: Yes

Was the Report Sent to FDA?

• Event Location: No Information
• Date Manufacturer Received: 10/20/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 09/07/2012
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Removal/Correction Number: Z-1060-2011

Patient Treatment Data

Date Received: 07/28/2017 Patient Sequence Number: 1