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

Model Number 8637-40

Device Problems Volume Accuracy Problem (1675); Insufficient Flow or Under Infusion (2182)

Patient Problem No Known Impact Or Consequence To Patient (2692)

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 professional (hcp) via manufacturer representative (rep) regarding a patient who was receiving unknown drug, unknown concentration at unknown dose via intrathecal drug delivery pump for non-malignant pain.It was reported that actual reservoir volume (arv) was greater than expected reservoir volume (erv).The rep was notified today about a patient that over the past 2 refills they had noticed a volume discrepancy where the arv was greater than the erv.The rep stated at the last refill the hcp was expecting 5 ml and the arv was 10 ml.The rep reported that the pump logs were checked.The rep reported the catheter access port (cap) was aspirated.The rep stated pump logs showed no motor stalls.The rep stated the catheter access port (cap) was aspirated and he was not sure if a dye study was done.The rep would be speaking to the hcp.No symptoms were reported.Additional information was received from a manufacturer representative.It was reported that the arv and erv at the other refill were 8 ml and 5 ml.There was no cause determined.In order to resolve the issue the manufacturer representative attended the most recent refill.At the refill, it was determined that the volume was within the acceptable range.The event had been resolved.The manufacturer representative would meet with the hcp the afternoon of (b)(6) 2018 regarding the catheter.Additional information was received from a healthcare provider (hcp) via a company representative (rep) regarding a patient receiving intrathecal hydromorphone 16 mg/ml at 10.7 mg/day.It was reported the patient went to their pain clinic on (b)(6) 2018 for a round pump refill.The refill nurse told the hcp that the interrogation said there should be 10 mls in the reservoir.There was a volume discrepancy as the nurse claimed to withdraw 18 mls of drug from the reservoir.A replacement was scheduled for (b)(6) 2018.The pump was refilled with 40 mls until replacement.The pump would be returned.There were no environmental/external/patient factors that may have led or contributed to the issue and no diagnostics/troubleshooting performed.The pump replacement was completed four days later on (b)(6) 2018.The issue was resolved at the time of this report and the patient¿s status was ¿alive- no injury.¿ other medications the patient was taking at the time of the event were ¿unable to obtain, not available.¿ the patient¿s weight and medical his tory were ¿asked and would not be made available (legal/confidential reason).¿ there were no further complications reported at this time.

Manufacturer Narrative

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

Event Description

Additional information was received from a manufacturer representative (rep).It was reported that the item had been placed in mail.Tracking number was reported.No further complications were reported.

Manufacturer Narrative

The pump was returned and analysis found no anomalies.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: 7534302
• MDR Text Key: 108921230
• Report Number: 3004209178-2018-11534
• 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
• Report Date: 10/05/2018

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: 09/28/2015
• Device Model Number: 8637-40
• Device Catalogue Number: 8637-40
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/13/2018
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 05/21/2018
• Initial Date FDA Received: 05/22/2018
• Supplement Dates Manufacturer Received: 06/04/2018; 07/09/2018; 08/08/2018
• Supplement Dates FDA Received: 06/05/2018; 07/10/2018; 10/05/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 04/07/2014
• 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