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

Model Number 8637-40

Device Problems Failure to Interrogate (1332); Migration or Expulsion of Device (1395); Obstruction of Flow (2423); Human-Device Interface Problem (2949); Material Integrity Problem (2978)

Patient Problems Muscular Rigidity (1968); Therapeutic Response, Decreased (2271); Sweating (2444); Confusion/ Disorientation (2553)

Event Date 01/10/2020

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 and a consumer via a company representative regarding a patient receiving lioresal dose and concentration not reported via an implantable pump.The indication for use was intractable spasticity.The patient¿s medical history included a cerebral shunt and spasticity.On 10-jan-2020 it was reported that the patient reported signs and symptoms of baclofen withdrawal.The patient symptoms were sweating, confusion and increased spasticity.The patient was seen today for a dye study to rule out a catheter issue.The diagnostics and troubleshooting performed was in radiology they tried to perform the dye study and they were unsuccessful due to the pump had flipped.They could not read the pump nor perform the dye study.Per the patient¿s mother, they were going to the surgeon on monday since he implanted the pump.The interventions and actions taken to resolve the issue was oral baclofen was given to the patient.The issue was not resolved at the time of the event.The patient status was noted as alive, no injury and no further complications were reported or anticipated.

Manufacturer Narrative

Product id 8709sc, serial# (b)(4), implanted: (b)(6) 2011.Product type catheter.Information references the main component of the system.Other relevant device(s) are : product id: 8709sc, serial# (b)(4), ubd 2013-10-05, udi# (b)(4).If information is provided in the future, a supplemental report will be issued.

Event Description

Additional information received from the healthcare provider reported that the actions and interventions taken to resolve the flipped pump was they fixed it on (b)(6) 2020, untwisted and re-implanted, good csf (cerebral spinal fluid) flow.The devices remained implanted.No further complications were reported or anticipated.

• 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: 9585948
• MDR Text Key: 174942565
• Report Number: 3004209178-2020-00961
• Device Sequence Number: 1
• Product Code: LKK
• UDI-Device Identifier: 00643169530126
• UDI-Public: 00643169530126
• 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,consum
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 01/22/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/14/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 08/14/2019
• Device Model Number: 8637-40
• Device Catalogue Number: 8637-40
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 01/17/2020
• Date Device Manufactured: 02/27/2018
• 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: 28 YR