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); Obstruction of Flow (2423); Aspiration Issue (2883); Infusion or Flow Problem (2964)

Patient Problems Pain (1994); Malaise (2359); Shaking/Tremors (2515)

Event Date 06/04/2018

Event Type  Injury  

Manufacturer Narrative

Concomitant medical products: product id: 8781, serial# (b)(4), implanted: (b)(4) 2016, product type: catheter.Other relevant device(s) are: product id: 8781, serial/lot #: (b)(4), (b)(6), (b)(4).If information is provided in the future, a supplemental report will be issued.

Event Description

Information was received from a healthcare provider (hcp) and consumer via a company representative (rep) regarding a patient receiving intrathecal morphine 2 mg/ml at 0.87 mg/day via an implanted pump for an unknown indication.The event/difficulty occurred on (b)(6) 2018 during normal use and it was noted the patient was scheduled for a dye study on (b)(6) 2018.The patient reported on (b)(6) 2018 he had an episode where he ¿did not feel good¿ and had involuntary shaking of his lower extremities.The pump was interrogated and no alarms were noted in the logs.The patient and physician stated that the refills have all been normal.The environmental/external/patient factors that may have led or contributed to the issue was noted as ¿n/a.¿ the dye study was attempted, and the physician was not able to aspirate the catheter under fluoro with two different catheter access port (cap) needles.The physician was comfortable with the bolus the patient would get if he injected dye into the catheter.He attempted to inject through the cap and was met with resistance.The issue was not resolved at the time of this report and the patient¿s status was ¿alive-no injury.¿ the patient would be scheduled for a catheter exploration/revision and date was to be determined.Other medications the patient was taking at the time of the event was ¿unable to obtain, not available.¿ the patient¿s weight and medical history were asked and would not be made available (legal/confidential reason).No further complications were reported/anticipated or expected.

Manufacturer Narrative

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

Event Description

Additional information was received from a healthcare provider (hcp) indicated the date of the catheter exploration/revision was b)(6) 2018.The cause of the inability to aspirate and resistance while injecting dye into the catheter was a catheter occlusion.It was noted the patient was given oral morphine to cover pain.The event was not resolved as the patient was scheduled for a revision on b)(6) 2018.It was noted the catheter would be returned if explanted.No further complications were reported/anticipated or expected.

Manufacturer Narrative

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

Event Description

Additional information was received from a company representative (rep) indicated the catheter issue and symptoms have been resolved with the replacement.The catheter would not be returned as the customer discarded.No further complications were reported/anticipated or expected.

Manufacturer Narrative

Concomitant medical products: product id: 8781, serial# (b)(4), implanted: (b)(6) 2016, explanted: (b)(6) 2018, product type: catheter.If information is provided in the future, a supplemental report will be issued.

Event Description

Additional information was received from a company representative (rep) indicated they were at the catheter revision case now ((b)(6) 2018) and they were not sure if there were holes in the catheter.The healthcare provider (hcp) replaced the pump segment, but when they tried to aspirate they were not able to, so they replaced the whole catheter with an 8781.They were able to get good cerebrospinal fluid (csf) backflow.No further complications were reported/anticipated or expected.

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: 7625910
• MDR Text Key: 111903581
• Report Number: 3004209178-2018-14020
• 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: 10/04/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/21/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 08/14/2017
• 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: 08/08/2018
• Date Device Manufactured: 02/23/2016
• 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: 72 YR