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

Model Number 8637-20

Device Problems Occlusion Within Device (1423); Obstruction of Flow (2423); Device Operates Differently Than Expected (2913); Insufficient Information (3190)

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

Event Date 05/21/2018

Event Type  Injury  

Manufacturer Narrative

Product id: 8709sc, serial# (b)(4), implanted: (b)(6) 2010, product type: catheter.Other relevant device(s) are: product id: 8709sc, serial/lot #: (b)(4), ubd: (b)(6) 2011, udi#: (b)(4).If information is provided in the future, a supplemental report will be issued.

Event Description

Information was received from a healthcare provider (hcp) via a device manufacturer representative regarding a patient who was receiving an unknown drug via an implantable infusion pump for non-malignant pain and failed back surgery syndrome.It was reported that at the time of the patient's pump replacement, the hcp mentioned that the catheter was blocked, and a portion of the catheter was replaced.This made the patient "superstitious," so the patient wanted the hcp to take a second look.The hcp performed a dye study and confirmed both aspiration and flow into the intrathecal space.However, the hcp also discovered what looked like a kink in the lumbar subcutaneous space and a catheter advanced anterograde, then made a u-turn and moved retrograde.She did not like the placement and was concerned about the kink.A total catheter replacement was suggested.The patient was going to be sent for a full catheter revision, but surgery was not scheduled at the time of the report.It was noted that the cause was uncertain, but it was likely that the difficulty occurred at the time of implant and was never diagnosed because the system was patent.The issue was not resolved at the time of the report.The patient's status at the time of the report was alive - no injury.No further complications were reported.

Manufacturer Narrative

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

Event Description

Additional information was received from the healthcare provider (hcp) via a device manufacturer representative.It was reported that the catheter was revised on (b)(6) 2018 and the patient reported doing well.No further complication was 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): 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: lisa woodward clark ; 7000 central avenue ne rcw215; minneapolis, MN 55432 ; 7635263920
• MDR Report Key: 7534525
• MDR Text Key: 108980353
• Report Number: 3004209178-2018-11548
• Device Sequence Number: 1
• Product Code: LKK
• UDI-Device Identifier: 00643169508149
• UDI-Public: 00643169508149
• 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: 10/04/2018

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: 07/28/2018
• Device Model Number: 8637-20
• Device Catalogue Number: 8637-20
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 05/21/2018
• Initial Date FDA Received: 05/22/2018
• Supplement Dates Manufacturer Received: 07/06/2018; 08/08/2018
• Supplement Dates FDA Received: 07/09/2018; 10/03/2018
• Date Device Manufactured: 02/06/2017
• 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: 77 YR