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

Model Number 8637-40

Event Date 01/01/2018

Event Type  Injury  

Manufacturer Narrative

Concomitant medical products: product id: 8780, serial# (b)(4), implanted: (b)(6) 2014, product type: catheter.Other relevant device(s) are: product id: 8780, serial/lot #: (b)(4), ubd: 07-feb-2016, udi#: (b)(4).If information is provided in the future, a supplemental report will be issued.

Event Description

Information was received from a healthcare professional (hcp) via a company representative and from a consumer regarding a patient receiving baclofen via an implanted pump.The indication for pump use was multiple sclerosis and intractable spasticity.On 14-feb-2019 the hcp reported to the company representative that the patient was not getting relief of her spasms and there was possible catheter occlusion.There were no environmental, external, or patient factors that may have led or contributed to the issue.The hcp had done regular x-rays and now the patient was scheduled for an mri on (b)(6) 2019.The issue was not resolved at the time of the report and it was unknown if surgical was planned.It was noted that the hcp had no further information to provide regarding the event.The patient status was reported a ¿alive ¿ no injury¿.Additional information was received on 14-feb-2019 from the patient who reported that her pump was malfunctioning.Per the patient, it had been going on for quite some time now.She clarified that it had gotten brutal.She was cramping from her toes to her hips.She was incontinent now, in pain, and could barely walk or stand for 5 minutes.Per the patient, her doctor thought it could be a fracture of the catheter, displacement of the catheter, a general catheter malfunction, or the pump could be cycling incorrectly.She was going to be getting an mri to diagnose the issue.No further complications have been reported as a result of this event.

Manufacturer Narrative

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

Event Description

Additional information was received that reported the patient was scheduled for pump and catheter replacement but it had to be cancelled due to an outbreak of shingle near the operative site.The patient would be rescheduled following treatment.No further complications were reported or anticipated.

Manufacturer Narrative

Product id: 8780, serial# (b)(4), implanted: (b)(6) 2014, product type: catheter.If information is provided in the future, a supplemental report will be issued.

Event Description

Additional information was received from the consumer indicated that the pump was replaced prematurely because it had been "dying for quite awhile".No further complications have been reported.

Manufacturer Narrative

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

Event Description

Additional information was received via a company representative.It was reported that during the implant procedure on (b)(6) 2018 (previously reported as (b)(6) 2019), the spinal portion of the catheter became damaged.During the procedure, they then used a new spinal portion of catheter and the pump portion from the original catheter regarding the catheter replacement/revision.

Manufacturer Narrative

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

Event Description

Additional information was received that reported in clarification of the report of the 8780 spinal portion of catheter having become damaged during the procedure, the spinal catheter was passed through the needle and was obstructed by scar tissue and curled up.The physician had to withdraw the catheter and did not want to use the same catheter as the guidewire was curved.Regarding the catheter damage during the procedure, it was reported no device issue because the catheter hit and obstruction it curved, and the physician wanted a new straight guidewire.No further complications were reported or anticipated.

Manufacturer Narrative

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

Event Description

Additional information was received that reported the actions and interventions taken to resolve the patient¿s symptoms was on (b)(6) 2019 the pump and catheter were replaced.The cause for the patient¿s symptoms was reported as no csf (cerebral spinal fluid) was returned from the existing catheter, so it was assumed it was occluded.The patient¿s weight was reported as about (b)(6).The patient¿s medical history included multiple sclerosis.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: 8347544
• MDR Text Key: 140016833
• Report Number: 3004209178-2019-03397
• Device Sequence Number: 1
• Product Code: LKK
• UDI-Device Identifier: 00643169100824
• UDI-Public: 00643169100824
• 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,Followup,Followup,Followup
• Report Date: 07/23/2019

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: 08/28/2015
• Device Model Number: 8637-40
• Device Catalogue Number: 8637-40
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 02/14/2019
• Initial Date FDA Received: 02/18/2019
• Supplement Dates Manufacturer Received: 03/13/2019; 04/23/2019; 04/15/2019; 04/26/2019; 07/22/2019
• Supplement Dates FDA Received: 03/18/2019; 04/24/2019; 04/25/2019; 04/29/2019; 07/23/2019
• Date Device Manufactured: 03/11/2014
• 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: 56 YR
• Patient Weight: 91