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

Model Number 8637-20

Device Problems Migration or Expulsion of Device (1395); Detachment of Device or Device Component (2907)

Patient Problem Granuloma (1876)

Event Date 11/04/2020

Event Type  Injury  

Manufacturer Narrative

Concomitant medical products: product id: 8731, serial#:(b)(4), implanted: (b)(6) 2020, product type: catheter. Other relevant device(s) are: product id: 8731, serial/lot #: (b)(4), ubd: 14-feb-2007, udi#:(b)(4). If information is provided in the future, a supplemental report will be issued.

Event Description

Information was received from a consumer via a device manufacturer representative regarding a patient receiving morphine (40 mg/ml at 12. 5mg/day) and "mixture of clonidine and marcaine" but the representative wasn't sure, via an implantable infusion pump. It was r eported that the patient has an inflammatory mass at her l5-s1 spinal area and a dye study was being done to check the catheter. The dye study was performed and showed that the dye appeared to go retrograde and the catheter appeared to be in the lower area of the spine, around l5-s1. There appeared to be a "tip" from an old catheter in the thoracic area, but no dye reached that area. Dye stayed in the lower lumbar area. The doctor planned to wean the patient down and then do a catheter revision. The patient had no therapy complaints and was getting good pain relief. The issue was not resolved. No further complications were reported.

• Brand Name: SYNCHROMED II
• Type of Device: PUMP, INFUSION, IMPLANTED, PROGRAMMABLE
• Manufacturer (Section D): MEDTRONIC PUERTO RICO OPERATIONS CO.; road 31, km. 24, hm 4; ceiba norte industrial park; juncos PR 00777
• Manufacturer (Section G): MEDTRONIC PUERTO RICO OPERATIONS CO.; road 31, km. 24, hm 4; ceiba norte industrial park; juncos PR 00777
• Manufacturer Contact: david gustafson ; 7000 central avenue ne rcw215; minneapolis, MN 55432 ; 7635149628
• MDR Report Key: 10809943
• MDR Text Key: 215340131
• Report Number: 3004209178-2020-19588
• 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,consum
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 11/09/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/09/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes

Device Operator

• Device Expiration Date: 07/28/2019
• Device Model Number: 8637-20
• Device Catalogue Number: 8637-20
• Was Device Available for Evaluation?: No

Is the Reporter a Health Professional?

Was the Report Sent to FDA?

• Event Location: No Information
• Date Manufacturer Received: 11/04/2020
• Was Device Evaluated by Manufacturer?: No Answer Provided
• Date Device Manufactured: 02/01/2018
• 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: 11/09/2020 Patient Sequence Number: 1

Treatment

"SEE H10...."