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

Model Number 8637-20

Device Problems Shelf Life Exceeded (1567); Human-Device Interface Problem (2949)

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

Event Date 04/03/2017

Event Type  malfunction  

Manufacturer Narrative

The main component of the device system; the other relevant components include: product id: 8840, product type: programmer, physician.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 foreign healthcare provider (hcp) via a manufacturer¿s representative regarding a patient who was receiving baclofen (3000 mcg/ml at 144.1 mcg/day) via an implantable pump for an unknown indication for use.It was reported that, on (b)(6) 2017, the patient was given a bolus volume of baclofen that was greater than it should have been.The patient¿s daily dose was reduced by 71%, and the volume of the bolus was administered over 2 hours, as opposed to the 44 minutes that was the shortest time shown on the nvision programmer.The patient was monitored post-op and no adverse incidents, symptoms, or signs of overdose occurred.This was due to the initial reduction of daily dose of baclofen.The patient was seen by a member of the rehab team, and the representative was told that the patient was fine.There were no signs of any complications, but the event must be reported as it should have never happened.There were no reported environmental, external, or patient factors that may have led or contributed to the issue.No surgical intervention was planned or occurred.It was unknown if the issue was resolved.The patient status was alive ¿ no injury.No complications were reported or anticipated.The patient¿s concomitant medications included oral baclofen; other medications were not known.The patient¿s medical history included cerebral palsy.It was noted the implant date of the pump was (b)(6) 2017, but the use before date (ubd) was 2015-jul-28.Verification of this implant date was being followed up for.

Manufacturer Narrative

(b)(4).

Manufacturer Narrative

Information references the main component of the system and other applicable components are: product id 8840, product type programmer, physician.Product id 8840, product type programmer, physician.

Event Description

On (b)(6) 2017, additional information was received from a foreign manufacturer representative (rep).Additional information reported the programmed length of the pump segment was 27.9 cm.The programmed length of the spinal segment was 86.4 cm with 22.8 cm removed.The bolus programmed was a priming bolus.The catheter volume was 0.201 ml with pump tubing volume of 0.140 ml, therefore, the bolus volume of 0.341 ml and priming bolus selected.In regards to the implant date discrepancy, the rep reported only the catheter was changed on (b)(6) 2017 and the pump remained from a previous surgery.

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: 6536886
• MDR Text Key: 74222245
• Report Number: 3004209178-2017-09451
• Device Sequence Number: 1
• Product Code: LKK
• Combination Product (y/n): N
• Reporter Country Code: UK
• PMA/PMN Number: P860004
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup,Followup
• Report Date: 06/27/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/02/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 07/28/2015
• Device Model Number: 8637-20
• Device Catalogue Number: 8637-20
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 06/27/2017
• Date Device Manufactured: 01/30/2014
• 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 Age: 29 YR