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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 Pumping Stopped (1503); Battery Problem (2885)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 04/01/2021
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 provider via a company representative regarding a patient receiving compounded baclofen 2 00mcg/ml at 991mcg/day, clonidine 200mcg/ml at 99. 18mcg/day and bupivacaine 200mcg/ml at 13mg/day via an implantable pump. The patient¿s medical history included ms (multiple sclerosis). It was reported that the patient missed scheduled replacements due to covid and other factors, transportation etc. The patient's pump had a motor stall occur that has not recovered. The pump stalled on (b)(6) 2021. The patient did not have an mri or any other emi/magnetic interactions. The environmental, external or patient factors that may have led or contributed to the issue was the patient was not able to come for scheduled replacement. The diagnostics and troubleshooting performed was log interrogation. Surgical intervention was planned and scheduled for (b)(6) 2021. Additional information was received on (b)(6) 2021 and it was reported that the pump was replaced today, and they added a new pigtail. They were able to aspirate the catheter.
 
Manufacturer Narrative
Analysis results were not available at the time of this report. A follow-up report will be sent when analysis is completed. If information is provided in the future, a supplemental report will be issued.
 
Event Description
Additional information received reported that the physician reported a motor stall on pump with greater 5 months eri (elective replacement indicator). The patient was a high dose baclofen patient. The pump was removed due to the battery depleted. No rotor or dye study was performed. The patient recovered without sequela.
 
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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
david gustafson
7000 central avenue ne rcw215
minneapolis, MN 55432
7635149628
MDR Report Key11627870
MDR Text Key253113936
Report Number3004209178-2021-05610
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
Remedial Action Notification
Type of Report Initial,Followup,Followup
Report Date 06/24/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received04/07/2021
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date04/14/2016
Device Model Number8637-40
Device Catalogue Number8637-40
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer04/15/2021
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received06/11/2021
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured10/24/2014
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial
Removal/Correction NumberZ-0497-2013

Patient Treatment Data
Date Received: 04/07/2021 Patient Sequence Number: 1
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