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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 No Audible Alarm (1019); Electromagnetic Interference (1194); Pumping Stopped (1503)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 03/06/2022
Event Type  Injury  
Event Description
Information was received from a healthcare provider (hcp) via a company representative regarding a patient receiving fentanyl (900 mcg/ml at 400 mcg/day) and bupivacaine (10 mg/ml) via an implanted pump. The indication for pump use was spinal pain. It was reported that the hcp noticed a motor stall alert last week when they refilled the pump, but they still refilled it. The logs show the stall occurred on (b)(6) 2022 and has not recovered. The patient was not having any symptoms and had not heard an alarm. An alarm test was done, and the patient could hear it at that point. No mri had been done. The pump was read multiple times just to be sure it couldn't have been in telemetry mode, but no recovery message was noted in the logs.
 
Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.
 
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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 Key13860187
MDR Text Key287680752
Report Number3004209178-2022-03588
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 Health Professional,Company Representative
Reporter Occupation
Remedial Action Notification
Type of Report Initial,Followup,Followup
Report Date 04/20/2022
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received03/23/2022
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date10/14/2018
Device Model Number8637-40
Device Catalogue Number8637-40
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Date Manufacturer Received04/18/2022
Was Device Evaluated by Manufacturer? No Answer Provided
Date Device Manufactured04/21/2017
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: 03/23/2022 Patient Sequence Number: 1
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