MAUDE Adverse Event Report: MEDTRONIC NEUROMODULATION SYNCHROMED II PUMP, INFUSION, IMPLANTED, PROGRAMMABLE

Model Number 8637-20

Device Problems Migration or Expulsion of Device (1395); Protective Measures Problem (3015)

Patient Problem Pain (1994)

Event Type  Injury  

Manufacturer Narrative

Concomitant medical products: product id: neu_unknown_cath, lot# unknown, product type: catheter. Other relevant device(s) are: product id: neu_unknown_cath, serial/lot #: unknown. If information is provided in the future, a supplemental report will be issued.

Event Description

Information was received from a foreign healthcare provider (hcp) via social media ((b)(6)) regarding a patient who was receiving morphine (unknown concentration and dose) via an implantable pump for abdominal pain from advanced pancreatic cancer. It was reported there was excellent pain control with the spinal infusion pump (synchromed ii) during the first 6 months. The patient was under chemotherapy treatment. Afterwards, the patient started complaining of a progressive increase of their habitual pain, despite increasing morphine daily dose and adding bupivacaine. The patient needed repeated high daily doses of short acting fentanyl. During the next pump refill, continuous fluoroscopy was done to check the catheter. The hcp couldn't confirm it, because only the tip of the catheter was radiopaque and it was difficult to see. Finally, a ct scan was made and informed by a radiologist, describing the stability of the tumor and the misplacement of the catheter. The catheter was placed in a subcutaneous plane, so the hcp went again to surgery. Further complications were not reported.

• Brand Name: SYNCHROMED II
• Type of Device: PUMP, INFUSION, IMPLANTED, PROGRAMMABLE
• Manufacturer (Section D): MEDTRONIC NEUROMODULATION; 800 53rd ave ne; minneapolis MN 55421 1200
• Manufacturer (Section G): MEDTRONIC NEUROMODULATION; 800 53rd ave ne; minneapolis MN 55421 1200
• Manufacturer Contact: lisa woodward clark ; 7000 central avenue ne rcw215; minneapolis, MN 55432 ; 7635263920
• MDR Report Key: 8612205
• MDR Text Key: 145125479
• Report Number: 3007566237-2019-01072
• Device Sequence Number: 1
• Product Code: LKK
• Combination Product (y/n): N
• Reporter Country Code: SP
• PMA/PMN Number: P860004
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional,o

Reporter Occupation

• Type of Report: Initial,Followup
• Report Date: 06/07/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/15/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes

Device Operator

• Device Expiration Date: 10/28/2019
• Device Model Number: 8637-20
• Device Catalogue Number: 8637-20
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes

Was the Report Sent to FDA?

• Event Location: No Information
• Date Manufacturer Received: 05/30/2019
• Was Device Evaluated by Manufacturer?: No Answer Provided
• Date Device Manufactured: 04/30/2018
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial

Patient Treatment Data

Date Received: 05/15/2019 Patient Sequence Number: 1