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

Model Number 8637-20

Device Problem Fluid/Blood Leak (1250)

Patient Problems Muscular Rigidity (1968); Swelling (2091); Therapeutic Response, Decreased (2271); Injury (2348); Fluid Discharge (2686)

Event Date 06/30/2019

Event Type  Injury  

Manufacturer Narrative

Concomitant medical products: product id: 8781.Serial#: (b)(4), implanted: (b)(6) 2018, product type: catheter.Other relevant device(s) are: product id: 8781, serial/lot #: (b)(4), ubd: 29-may-2020, udi#: (b)(4).If information is provided in the future, a supplemental report will be issued.

Event Description

Information was received from the healthcare provider (hcp) regarding a patient receiving baclofen (2050 mcg/day at 308 mcg/day) via an implantable infusion pump.The indication for use was intractable spasticity.It was reported that the patient was having reconstructive surgery and it was noticed that the spinal segment of the catheter was leaking.The leak was also confirmed on the ct scan.No symptoms were reported.The caller stated that they wanted to have the pump interrogated.No further complications have been reported as a result of this event.Additional information was received from a healthcare professional (hcp) and a consumer via a manufacturer's representative (rep).It was reported that the patient experienced a loss of therapy and a wound on their back with a return of spasticity.The pump was placed at minimum rate.The patient's father noted some swelling and drainage from the wound.A dye study was performed in the or and no leaks were found.The spinal pocket was opened and examined but results of this were unknown.The issue was resolved at the time of the report and the patient's status was noted as "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 a healthcare professional (hcp) on 2019-jul-19.It was reported that the cause of the leak was unknown.The catheter segment was revised.The issue was resolved.The patient's weight was unknown.No further complications were reported.

• 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: 8768029
• MDR Text Key: 150283419
• Report Number: 3004209178-2019-13068
• Device Sequence Number: 1
• Product Code: LKK
• UDI-Device Identifier: 00643169630505
• UDI-Public: 00643169630505
• 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: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 07/19/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/08/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 03/28/2020
• Device Model Number: 8637-20
• Device Catalogue Number: 8637-20
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 07/19/2019
• Date Device Manufactured: 10/03/2018
• 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: 19 YR
• Patient Weight: 39