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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 8637-20
Device Problems Unstable (1667); Volume Accuracy Problem (1675); Device Operates Differently Than Expected (2913)
Patient Problem Pain (1994)
Event Date 06/06/2018
Event Type  Injury  
Manufacturer Narrative
Concomitant medical products: product id: 8781, serial# (b)(4), implanted: (b)(6) 2018, explanted: (b)(6) 2018, 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 professional (hcp) via a manufacturer's representative (rep) regarding a patient who was receiving 15mcg/ml prialt at 1. 2mcg/day and 15mg/ml bupivacaine at 1. 2mg/day via an implantable infusion pump for an unknown indication for use. It was reported that the patient reported an increase in pain over the last three months. At a refill the full volume was extracted from the pump. It was reported that the patient twiddled the pump. The patient was scheduled for surgery, and during the surgery it was discovered that the patient was a "twiddler," and had twisted the pump around multiple times. The catheter was replaced. It was reported that the patient received effective therapy after the surgery. It was reported that the issue was resolved at the time of the report. The patient's status was reported as "alive-no injury. " no further complications were anticipated/reported.
 
Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.
 
Manufacturer Narrative
Concomitant medical products: product id: 8781, serial# (b)(4), implanted: (b)(6) 2018, 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 manufacturer's representative. It was reported that the healthcare professional (hcp) preferred to do a catheter replacement instead of a revision. It was reported the cause of the volume discrepancy was not determined. The hcp decided the best way to insure proper delivery of the drug was to do a catheter replacement. No further complications were anticipated/reported.
 
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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 Key7589379
MDR Text Key110702824
Report Number3004209178-2018-13130
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,Followup
Report Date 10/05/2018
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received06/11/2018
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date06/14/2018
Device Model Number8637-20
Device Catalogue Number8637-20
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 Received08/08/2018
Was Device Evaluated by Manufacturer? No Answer Provided
Date Device Manufactured12/14/2016
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: 06/11/2018 Patient Sequence Number: 1
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