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

Model Number 8637-20

Device Problems Failure to Interrogate (1332); Kinked (1339); Device Displays Incorrect Message (2591); Communication or Transmission Problem (2896)

Patient Problems Muscular Rigidity (1968); No Known Impact Or Consequence To Patient (2692)

Event Date 05/27/2016

Event Type  Injury  

Manufacturer Narrative

The main component of the system and other applicable components are: concomitant product: product id neu_unknown_prog, product type programmer, physician; product id neu_unknown_catheter, product type programmer, physician.

Event Description

Information was received from a healthcare provider (hcp) via a company representative regarding a patient in switzerland receiving intrathecal lioresal (concentration 500mcg/ml; dose 25mcg/day) via an implantable infusion pump.On (b)(6) 2016, the patient presented for a pump refill at which time the hcp refilled the pump with saline.Upon reprogramming of the pump, the clinician programmer signaled an error on the screen of broken programmer and shut off.The hcp attempted to reprogram the pump and the pump stopped message displayed on the screen.The hcp was unable to reprogram the pump as the same message appeared.There were no environmental/external/patient factors that may have led or contributed to the issue.No diagnostics or troubleshooting was performed.The issue was not resolved and the plan was to replace the pump; no date had yet been set.At the time of this report, patient status was ¿alive with no injury.¿ additional information was received from a hcp via a company representative.The hcp had tried using a different programmer but could not reprogram the pump.It was unknown if the pump stop was indicated in the pump logs.The patient experienced increased spasticity as a result.The plan was to replace the pump on (b)(6) 2016 and the pump was expected to be returned upon explant.A new pump and catheter were implanted on (b)(6) 2016.Upon opening the scar in the back, the catheter was found to be kinked near the anchor (intrathecal part).The new pump was filled with lioresal 500 mcg/ml with a continuous rate of 25 mcg/day.

Manufacturer Narrative

Analysis results were not available at the time of this report.A follow-up report will be sent when analysis is completed.Evaluation conclusion code no longer applies for the pump.

Event Description

Additional information was received from a hcp via a company representative.The hcp had tried using a different programmer but could not reprogram the pump.It was unknown if the pump stop was indicated in the pump logs.The patient experienced increased spasticity as a result.The plan was to replace the pump on (b)(6) 2016 and the pump was expected to be returned upon explant.On (b)(6) 2016 (b)(4): a new pump and catheter were implanted on (b)(6) 2016.Upon opening the scar in the back, the catheter was found to be kinked near the anchor (intrathecal part).The new pump was filled with lioresal 500 mcg/ml with a continuous rate of 25 mcg/day (b)(6) 2016, (b)(4) (for, rep): additional information was received from the manufacturing representative on (b)(6) 2016.The serial number of the programmer was provided.The model and lot number of the kinked catheter was unknown.The catheter was explanted on (b)(6) 2016.

Manufacturer Narrative

Pump conclusion code no longer applies to this event.

Manufacturer Narrative

Additional information received indicated the product was received by the company at an international site, and was shipped to a different site for analysis; however, the product has not been received at the site to perform analysis.The current device location is unknown and an investigation is ongoing to locate the device.

Manufacturer Narrative

Analysis of the pump (sn (b)(4)) found the pump exterior had impact dents that did not affect post-explant pump performance.The pump catheter access port (cap) was aspirated and found to be patent.The pump was tested within specifications for dispense accuracy at 300 mcl/day and 24,000 mcl/day.The battery voltage was tested within specification.Visual inspection of the hybrid (circuit board) did not identify any anomalies.Destructive analysis of the motor assembly did not identify any anomalies.Pressure testing did not identify any leaks or breaches in the internal pump tube.The pump passed all destructive and non-destructive analysis testing, including being programmed multiple times during the course of decontamination, analysis, and testing.Analysis of the catheter (lot # unknown) found a kink was observed in the catheter body and there was a compressed area in the catheter body.

Manufacturer Narrative

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

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 clark ; 7000 central avenue ne rcw215; minneapolis, MN 55432 ; 7635263920
• MDR Report Key: 5731843
• MDR Text Key: 47588368
• Report Number: 3004209178-2016-12417
• Device Sequence Number: 1
• Product Code: LKK
• Combination Product (y/n): N
• Reporter Country Code: SZ
• PMA/PMN Number: P860004
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup,Followup,Followup
• Report Date: 03/21/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/17/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 02/14/2017
• Device Model Number: 8637-20
• Device Catalogue Number: 8637-20
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/22/2016
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 03/17/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 08/14/2015
• 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