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

Model Number 8637-40

Device Problems Kinked (1339); Aspiration Issue (2883); Device Operates Differently Than Expected (2913); Material Integrity Problem (2978)

Patient Problems Itching Sensation (1943); Muscle Spasm(s) (1966); Muscular Rigidity (1968); Sedation (2368)

Event Date 03/14/2017

Event Type  Injury  

Manufacturer Narrative

The main component of the system and other applicable components are: product id: 8780, serial# (b)(4), implanted: (b)(6) 2015, product type: catheter.A good faith effort will be made to obtain the applicable information relevant to the report.If information is provided in the future, a supplemental report will be issued.

Event Description

Information was received from a healthcare professional via a company representative regarding a patient receiving baclofen (2000 mcg/ml at 1209 mcg/day) via an implanted pump.The indication for pump use was cerebral palsy and intractable spasticity.On 20-mar-2017 it was reported that starting last tuesday ((b)(6)2017) the patient and family reported increased spasms.The patient had a pump refill on thursday and the refill went normal with expected volume similar to the actual volume.On friday the patient developed itching and increasing tone.The patient was admitted to the hospital.On sunday a side port aspiration was attempted and that was unsuccessful along with a 10% increase in dose.Today a second attempt at a side port aspiration was attempted unsuccessfully.A single bolus of 50 mcg was given today.The patient would have a 50 mcg bolus every 4 hours and their response would be noted.If the bolus did not help the patient then a catheter revision may be considered.It was reported that it was unknown if any environmental, external, or patient factors that may have led or contributed to the issue.The issue was not resolved.The patient status was reported as ¿alive ¿ no injury¿.No further patient complications have been reported as a result of this event.

Event Description

Additional information was received and it was reported that the patient had a catheter revision on (b)(6) 2017.The spinal incision was opened and the anchor was dissected out.The catheter appeared sharply bent around the distal end of the anchor.That area was freed up and csf (cerebrospinal fluid) flow was restored.The anchor and surrounding catheter was removed for a total of 12.5 cm.A new connector was used to reconnect the catheter and the patency was again checked and the csf was flowing.The incision was closed, the dose was reduced by 10%, and a 50 mcg bolus was ordered following the catheter prime.Per the physician, the therapy was restored.No further complications were reported/anticipated.

Event Description

Additional information received reported the actions/interventions taken to resolve the inability to aspirate the side port was the patient was taken to the or (operating room) and noted to have a kink in the catheter.The cause for the inability to aspirate was kink in the catheter.The inability to aspirate and the patient¿s symptoms were resolved.It was also noted that the physician was concerned that the catheter is no longer radiopaque.The physician felt that in this case the ability to visualize the catheter would have diagnosed the problem in a quicker fashion.No further complications were reported/anticipated.

Manufacturer Narrative

A good faith effort will be made to obtain the applicable information relevant to the report.If information is provided in the future, a supplemental report will be issued.

Manufacturer Narrative

Analysis results were not available at the time of this report.A follow-up report will be sent when analysis is completed.Conclusion code is no longer applicable for this event.

Event Description

Additional information was received and it was reported that the patient¿s medical history included dystonic quadriparesis.The patient¿s concomitant medication was sinemet (carbidopa-levodopa) at 25-100 mg 2x/day.Following the procedure on (b)(6) 2017, the patient¿s baclofen dose was reduced to 855.9 g/day due to sedation which resolved after the reduction.On (b)(6) 2017, the patient was discharged from the hospital.No additional information was provided.No further patient complications have been reported as a result of this event.

Manufacturer Narrative

Analysis of the catheter found a kink in the catheter body.Eval code - conclusion code ¿ is being updated for this event.Eval code - result no longer applies.A good faith effort will be made to obtain the applicable information relevant to the report.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.

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: 6421069
• MDR Text Key: 70457281
• Report Number: 3004209178-2017-06019
• 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,health
• Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup,Followup,Followup
• Report Date: 05/15/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/21/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 09/14/2016
• Device Model Number: 8637-40
• Device Catalogue Number: 8637-40
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/29/2017
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 04/24/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/20/2015
• 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): Hospitalization; Required Intervention
• Patient Age: 16 YR