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

Model Number 8637-40

Device Problems Occlusion Within Device (1423); Aspiration Issue (2883); Device Operates Differently Than Expected (2913)

Patient Problem Pain (1994)

Event Date 12/01/2017

Event Type  Injury  

Manufacturer Narrative

The main component of the device system; the other relevant components include: product id: 8731sc, serial# (b)(4), implanted: (b)(6) 2010, explanted: (b)(6) 2018, product type: catheter.If information is provided in the future, a supplemental report will be issued.

Event Description

Information was received from a healthcare professional via a manufacturer's representative regarding a patient who was receiving 5m g/ml morphine at ".24" via an implantable infusion pump for an unknown indication for use.It was reported that the patient developed increased pain 1 week after falling directly onto the pump.The patient stated they fell directly on to the pump catheter connection.The catheter was unable to be aspirated.The pump segment of the catheter was replaced and they were able to pull back cerebrospinal fluid.It was reported that the issue was resolved at the time of the report.The patient's status at the time of the report was noted as "alive-no injury." no further complications were anticipated/reported.

Manufacturer Narrative

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

Event Description

Additional information received reported that after removal of the pump connector from the pump and cutting a section from the catheter, csf (cerebral spinal fluid) flow was restored.This reporter was unsure what the problem was when trying to aspirate prior to cutting the catheter.They did attempt to withdraw csf (cerebral spinal fluid) from the catheter prior to cutting of the pump connector.The reporter was also unsure if the connector was damaged or clotted or a hole somewhere.However, when the catheter was cut csf (cerebral spinal fluid) began to flow.After the new segment was implanted csf (cerebral spinal fluid) was able to be pulled.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 consumer indicted the patient had an issue with the catheter back in january and had to have an operation on it.It was reported the catheter was ¿plugged¿ and this was discovered ¿when i had the operation back in january.¿ the catheter had been corrected.It was noted the dose and concentration of morphine was lower than what it was.No further complications were reported/anticipated or expected.

Manufacturer Narrative

Analysis of the catheter revealed sc connector coring, tears, cuts in seal.Recent fda coding changes offer limited options for medical device evaluation conclusion coding.Medtronic selected because, although the device was operating within specifications, medtronic modified the specifications making this the closest code available with respect to this event.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.

Event Description

Additional information was received from a consumer.It was reported that the patient had an issue with the catheter in late (b)(6)2017 and he had surgery.The patient was not getting any medication.It was noted that the medications were decreased to "almost off" until they could figure out what was wrong with the pump and the patient was given oral medication.It was reported that "the little port was not getting any fluid." the connector that connects to the pump was replaced.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: 7206192
• MDR Text Key: 97763578
• Report Number: 3004209178-2018-01008
• 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,consum
• Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup,Followup,Followup
• Report Date: 05/16/2018

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: 04/28/2018
• Device Model Number: 8637-40
• Device Catalogue Number: 8637-40
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/29/2018
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 01/11/2018
• Initial Date FDA Received: 01/19/2018
• Supplement Dates Manufacturer Received: 01/19/2018; 02/18/2018; 03/06/2018; 05/14/2018
• Supplement Dates FDA Received: 01/23/2018; 02/20/2018; 03/08/2018; 05/16/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 11/12/2016
• 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
• Patient Age: 49 YR
• Patient Weight: 78