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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 Problem Volume Accuracy Problem (1675)
Patient Problem Therapeutic Response, Decreased (2271)
Event Date 11/01/2017
Event Type  malfunction  
Manufacturer Narrative
Concomitant medical products: product id 8780, serial# (b)(4), implanted: (b)(6) 2015, product type catheter, udi# (b)(4). If information is provided in the future, a supplemental report will be issued.
 
Event Description
Information was received from a consumer and a healthcare provider (hcp) via a manufacturer representative regarding a patient who was receiving morphine 27 mg/ ml; 18. 011 mg /day via an implantable pump. Indication for use was spinal pain. The date of the event was (b)(6) 2018. It was reported the pump had increasing reservoir volume remaining at refills. At the last refill 2 ml remained in the pump and the hcp withdrew 6 mls. The patient experienced withdrawal symptoms occasionally at night. There were no environmental/external/patient factors that may have led or contributed to the issue. A dye and rotor study were conducted. No interventions were taken after the dye and rotor study. The pump and catheter were patent per the hcp. Surgical intervention did not occur and was not planned. The issue was resolved. Patient status was alive - no injury. Patient weight and medical history were asked but were unknown. 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 healthcare professional (hcp) via a manufacturer representative. The date of the event was approximately (b)(6) 2017. The patient first started experiencing withdrawal (b)(6) 2017. The actual residual volume (arv) and expected residual volume (erv) were only known from the last fill in (b)(6) 2018. The arv was 5-6 ml and the erv was 2. 7 ml. The cause of the volume discrepancy was not determined. A rotor and dye study were completed, and nothing was found.
 
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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 Key7510443
MDR Text Key108241407
Report Number3004209178-2018-10785
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,consum
Reporter Occupation
Type of Report Initial,Followup
Report Date 05/30/2018
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received05/14/2018
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date10/28/2016
Device Model Number8637-40
Device Catalogue Number8637-40
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? No
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received05/17/2018
Was Device Evaluated by Manufacturer? No Answer Provided
Date Device Manufactured05/07/2015
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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