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

Model Number 8637-20

Device Problems Kinked (1339); Migration or Expulsion of Device (1395); Aspiration Issue (2883); Material Integrity Problem (2978)

Patient Problems Pain (1994); Therapeutic Response, Decreased (2271)

Event Date 02/01/2018

Event Type  Injury  

Manufacturer Narrative

Concomitant medical products: product id: 8780, serial (b)(4), implanted: (b)(6) 2013, product type: catheter.The main component of the system.Other relevant device(s) are: product id: 8780, serial/lot (b)(4), ubd: 23-may-2015, (b)(4).If information is provided in the future, a supplemental report will be issued.

Event Description

Information was received from a healthcare professional (hcp) via a manufacturer representative (rep) regarding a patient who was receiving 2000 mcg/ml fentanyl at 99.7 mcg/day, 15.6 mg/ml bupivacaine at 0.778 mg/day, and 1 mg/ml morphine at 0.0498 mg/day via an implantable pump for non-malignant pain and lumbar radiculopathy.It was reported that two months ago, the patient had developed a return of her pain.On (b)(6) 2018, the doctor attempted a catheter access port (cap) dye study and was unable to aspirate from the cap.Today [(b)(6) 2018], the patient was having a catheter revision and they found a kink at the proximal end of the anchor.No further issues were reported or anticipated.

Manufacturer Narrative

The main component of the system and other applicable components are: product id: 8780, serial#: (b)(4), implanted: (b)(6) 2013, explanted: (b)(6) 2018, product type: catheter.If information is provided in the future, a supplemental report will be issued.

Event Description

Additional information was received from a healthcare provider (hcp) and a device manufacturer representative.It was reported that the patient had a catheter revision on (b)(6) 2018, and a new pump was placed that day as well.The elective replacement indicator was noted to be 23 months.It was further reported that the catheter was dislodged and coiled in the tissue.A catheter kink was also noted.No further complications were reported.

Manufacturer Narrative

The catheter was returned, and analysis found a kink in the catheter body.Medtronic, inc.(medtronic) is submitting this report to comply with 21 c.F.R.Part 803, the medical device reporting regulation.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: 7452547
• MDR Text Key: 106222906
• Report Number: 3004209178-2018-08628
• 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: company representative,health
• Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date: 06/06/2018

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: 12/28/2014
• Device Model Number: 8637-20
• Device Catalogue Number: 8637-20
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/26/2018
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 04/19/2018
• Initial Date FDA Received: 04/23/2018
• Supplement Dates Manufacturer Received: 04/19/2018; 05/11/2018
• Supplement Dates FDA Received: 05/01/2018; 06/06/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 07/03/2013
• 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: 34 YR
• Patient Weight: 57