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

Model Number 8637-40

Device Problem Occlusion Within Device (1423)

Patient Problems Unspecified Infection (1930); Complaint, Ill-Defined (2331)

Event Type  Injury  

Manufacturer Narrative

Other applicable components are: product id: 8780, serial# (b)(4), implanted: (b)(6) 2016, product type: catheter.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 company representative regarding a patient who was receiving gablofen with concentration 2000 mcg/ml at a dose rate of 775 mcg/day via an implantable pump for intractable spasticity and cerebral palsy.It was reported that the patient has been having complications as they been upping the dose and they think the catheter may be occluded.It was further reported that they were suspecting that the patient may have an active infection or they have a history of infection.The date of the event was unknown.It was unknown if the infection was related to device.There was no report of a pump alarm at this time.They plan to leave the pump in and program the pump to a minimum rate.No patient symptoms were noted.It was further noted that they plan to take the catheter out and replace the catheter or entire system at a later date.The product was to be returned to the manufacturer.No further patient complications have been reported as a result of this event.

Manufacturer Narrative

Analysis results were not available at the time of this report.A follow-up report will be sent when analysis is completed.If information is provided in the future, a supplemental report will be issued.

Event Description

Additional information was received from a company representative.The catheter component was returned to the manufacturer; received 2018-mar-05.

Manufacturer Narrative

Concomitant medical products: product id: 8780, serial# (b)(4), implanted: (b)(6) 2016, product type: catheter.(b)(4).A partial catheter was returned to the manufacturer.As per the manufacturer¿s device registry, the catheter was revised on (b)(6) 2018; a portion of the catheter was reused regarding the revision.Analysis of the catheter revealed no significant anomaly regarding the segment / incomplete catheter received.(b)(4).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 woodward clark ; 7000 central avenue ne rcw215; minneapolis, MN 55432 ; 7635263920
• MDR Report Key: 7296078
• MDR Text Key: 100917306
• Report Number: 3004209178-2018-03928
• Device Sequence Number: 1
• Product Code: LKK
• UDI-Device Identifier: 00643169508156
• UDI-Public: 00643169508156
• 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,Followup
• Report Date: 04/24/2018

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: 08/14/2017
• Device Model Number: 8637-40
• Device Catalogue Number: 8637-40
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/05/2018
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 02/22/2018
• Initial Date FDA Received: 02/26/2018
• Supplement Dates Manufacturer Received: 03/02/2018; 04/24/2018; 04/24/2018
• Supplement Dates FDA Received: 03/06/2018; 04/24/2018; 04/24/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 02/17/2016
• 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