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

Model Number 8637-20

Device Problems Volume Accuracy Problem (1675); Insufficient Flow or Under Infusion (2182); Obstruction of Flow (2423); Aspiration Issue (2883); Device Operates Differently Than Expected (2913)

Patient Problems Muscular Rigidity (1968); Therapeutic Response, Decreased (2271)

Event Date 03/26/2018

Event Type  Injury  

Manufacturer Narrative

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

Event Description

Information was received from a healthcare provider (hcp) regarding a patient who was receiving baclofen (500 mcg/ml at an unknown dosage) via an implantable infusion pump for intractable spasticity and cerebral palsy.Of note, the last time that the patient had a dose increase was in (b)(6) 2018.It was reported that the actual residual volume (arv) was greater than the expected residual volume (erv) at two refill appointments.On (b)(6) 2018, the arv was 8 ml while the erv was 3.1 ml.On (b)(6) 2018, the arv was 14.5 ml while the erv was 3.2 ml.The pump logs were checked, the reservoir was accessed, and the programming was checked.The hcp confirmed that there were no anomalies with the pump logs.Clinically, the patient was doing fine.The only thing was that the patient had been a little tight, but the patient was fine.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 a healthcare provider (hcp).It was reported that the hcp was still in the process of determining the cause of the volume discrepancies.The hcp was unable to aspirate from the catheter access port (cap).The volume discrepancies were not resolved at the time of the report.The device was still in place at the time of the report.The patient was stable at the time of the report.The patient was scheduled for follow up "this week." no further complications were reported.

Manufacturer Narrative

Concomitant medical products: product id: 8780, serial# (b)(4), implanted: (b)(6) 2017, product type: catheter.Product id: 8780, serial# (b)(4), implanted: (b)(6) 2017, product type: catheter.If information is provided in the future, a supplemental report will be issued.

Manufacturer Narrative

Analysis of the pump identified no anomalies.Analysis of the catheter identified no significant anomalies.The catheter was damaged at explant.The previously reported evaluation conclusion, result, and method codes no longer apply.If information is provided in the future, a supplemental report will be issued.

Manufacturer Narrative

Product id: 8780, serial# (b)(4), implanted: (b)(6) 2017, product type: catheter; product id: 8780, serial# (b)(4), implanted: (b)(6) 2017, explanted: (b)(6) 2019, product type: catheter.Analysis results were not available as of the date of this report.A follow-up report will be submitted when analysis is complete.The previously reported evaluation conclusion, method, and result codes no longer apply.If information is provided in the future, a supplemental report will be issued.

Event Description

Additional information was received from an hcp on 2019-apr-19.It was reported that the patient experienced an abrupt loss of therapy and the catheter appeared kinked at the anchor site.The hcp decided to replace the pump segment and the pump on (b)(6) 2019.There was no patient injury and the patient recovered without sequelae after the device was removed.It was specified that the baclofen in the pump was gablofen.

• 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: 7569436
• MDR Text Key: 110086535
• Report Number: 3004209178-2018-12592
• Device Sequence Number: 1
• Product Code: LKK
• UDI-Device Identifier: 00643169530119
• UDI-Public: 00643169530119
• 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: health professional
• Reporter Occupation: Health Professional
• Type of Report: Initial,Followup,Followup,Followup,Followup
• Report Date: 06/21/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/05/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 05/14/2019
• Device Model Number: 8637-20
• Device Catalogue Number: 8637-20
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/19/2019
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 06/20/2019
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 11/27/2017
• 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: 10 YR