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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 Insufficient Flow or Under Infusion (2182); Battery Problem (2885); Material Integrity Problem (2978)
Patient Problem Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)
Event Date 06/15/2021
Event Type  Injury  
Manufacturer Narrative
Concomitant medical products: product id 8780, serial# (b)(4), implanted: (b)(6) 2019, product type catheter. Other relevant device(s) are: product id: 8780, serial/lot #: (b)(4), ubd: 12-jan-2021, udi#: (b)(4). If information is provided in the future, a supplemental report will be issued.
 
Event Description
Information was received from a consumer (con) via a company representative (rep) regarding a patient with an implantable infusion p ump receiving morphine 10 mg/ml for dose and 6. 85 mg/day for concentration and hydrocodone 10/32. It was reported that patient presented for pump change today. According to patient, he was told by his hcp that the pump battery was failing and, as such, was not delivering the programmed daily dose. Patient was experiencing mild withdrawal symptoms from time to time between refills. Hcp performed a dye study several weeks ago with normal results. He states that pump reservoir volumes were much higher than expected at refills and they deduced the pump was failing since the catheter tested with no abnormality. Patient stated that his hcp recently doubled his drug concentration from 5mg/ml to10mg/ml to decrease the frequency of refills. Since that time, the patient has required increased daily doses to receive adequate analgesia. Logs showed no record of stalls. Upon observation at the surgery to replace the pump, the catheter was carefully coiled behind the pump and a full analysis revealed a patent pathway with back flow. A new pump was back table primed with the existing med from the old pump. The new pump was then placed in the existing pocket and connected to the existing catheter. It was carefully sutured in to place using the suture loops and incision was closed. It was reported that no falls or other events were reported that may have contributed to lack of efficacy. It is unknown if the issue was resolved at time of report.
 
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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
glen belmer
7000 central avenue ne rcw215
minneapolis, MN 55432
6122713209
MDR Report Key12264105
MDR Text Key264758406
Report Number3004209178-2021-11782
Device Sequence Number1
Product Code LKK
Combination Product (y/n)N
PMA/PMN Number
P860004
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,consum
Reporter Occupation Non-Healthcare Professional
Type of Report Initial,Followup,Followup
Report Date 10/21/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received08/02/2021
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date07/14/2020
Device Model Number8637-40
Device Catalogue Number8637-40
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer10/01/2021
Is the Reporter a Health Professional?
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received10/20/2021
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured01/24/2019
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: 08/02/2021 Patient Sequence Number: 1
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