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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 Problem Pumping Stopped (1503)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 01/30/2022
Event Type  malfunction  
Event Description
Information was received from a manufacturer representative regarding a patient who was receiving morphine (10 mg/ml at 4. 287 mg/day) and bupivacaine (2. 5 mg/ml at 1. 0717 mg/day) via an implantable pump for spinal pain indications. It was reported that the company representative (rep) stated that a pump that was implanted yesterday was currently alarming. The rep stated that there was no service code available. Rep read the logs and it was determined that the pump had stalled while on shelf state on jan 30 for close to 24 hours and on jan 31 and recovered both times. Technical services recommended silencing the pump alarm which was done successfully. No symptoms reported. Additional information received from the company representative stated that the patient weight was unknown.
 
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 Key14217841
MDR Text Key290148267
Report Number3004209178-2022-05289
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
Reporter Occupation Non-Healthcare Professional
Type of Report Initial
Report Date 04/27/2022
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received04/27/2022
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model Number8637-20
Device Catalogue Number8637-20
Was Device Available for Evaluation? No
Date Manufacturer Received04/20/2022
Was Device Evaluated by Manufacturer? No Answer Provided
Date Device Manufactured09/01/2021
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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