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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 Therapeutic Response, Decreased (2271)
Event Date 04/26/2018
Event Type  malfunction  
Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.
 
Event Description
On (b)(6) 2018, information was received from a healthcare professional (hcp) via a manufacturer representative (rep) regarding a patient receiving an unknown drug (unknown dose and concentration) via an implantable pump for non-malignant pain. On (b)(6) 2018, during a normal refill procedure, the 8840 (physician programmer) indicated there should be 5 ml (expected reservoir volume (erv)) of drug in the pump. The hcp aspirated the pump and the volume was 0 (actual reservoir volume (arv). The hcp indicated that they had been "getting more volume out of the reservoir before on a refill". No more specific information was provided regarding the previous volume discrepancies. The patient was "experiencing apparently some withdrawal symptoms". The ptm was "apparently" using a future date for an alarm date. The hcp refilled the pump as usual. The hcp scheduled the patient to return to the office in about a week to check the reservoir volume. There were no known environmental, external, or patient factors that may have led or contributed to the event. There were no known diagnostics or troubleshooting performed. The resolution of the event was unknown. The patient's status was alive - no injury.
 
Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.
 
Event Description
On (b)(6) 2018, additional information was received from a manufacturer representative (rep) which was confirmed with the healthcare professional (hcp). It reported the patient was receiving morphine (64 mg/ml, 65 mg/day), bupivacaine (12 mg/ml, 12. 197 mg/day), sufentanil (800 mcg/ml, 813. 10 mcg/day), gabapentin (30 mg/ml, 30. 491 mg/day) and fentanyl (450 mcg/ml, 457. 37 mcg/day). The rep reported the actions taken to resolve the event was "pump was refilled as normal". The exact volumes and dates of the previous volume discrepancies was unknown. The rep was "not sure" of the symptoms the patient was experiencing. The rep was "not sure" when the symptoms started. The rep was "not sure" about what future date the ptm was using.
 
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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 Key7473473
MDR Text Key106960377
Report Number3004209178-2018-09640
Device Sequence Number1
Product Code LKK
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
Report Date 05/21/2018
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received04/30/2018
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date12/28/2017
Device Model Number8637-40
Device Catalogue Number8637-40
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received05/20/2018
Was Device Evaluated by Manufacturer? No Answer Provided
Date Device Manufactured07/13/2016
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

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