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U.S. Department of Health and Human Services

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

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MEDTRONIC PUERTO RICO OPERATIONS CO. SYNCHROMED II PUMP, INFUSION, IMPLANTED, PROGRAMMABLE Back to Search Results
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.
 
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Brand NameSYNCHROMED II
Type of DevicePUMP, 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 Key7534302
MDR Text Key108921230
Report Number3004209178-2018-11534
Device Sequence Number1
Product Code LKK
UDI-Device Identifier00643169100824
UDI-Public00643169100824
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
P860004
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,health
Reporter Occupation
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
Date FDA Received05/22/2018
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date09/28/2015
Device Model Number8637-40
Device Catalogue Number8637-40
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer06/13/2018
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received08/08/2018
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured04/07/2014
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

Patient Treatment Data
Date Received: 05/22/2018 Patient Sequence Number: 1
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