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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 Volume Accuracy Problem (1675)
Patient Problem Pain (1994)
Event Date 03/01/2018
Event Type  malfunction  
Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.
 
Event Description
Information was received from a consumer regarding a patient receiving morphine at an unknown concentration and dose via an implantable infusion pump. The indications for use were noted to be non-malignant pain and chronic low back pain. It was reported that for the past two months (relative to (b)(6) 2018), when the patient went to the doctor for a refill, the physician's assistant who did the refill kept telling the patient that " a lot of the medication [was] still in there" and she thought the patient wasn't using the boluses. The patient noted she was still using the boluses like she had been for 5 years. She did not have the volumes as the pa had not told her, but they had confirmed that it happened at every refill since (b)(6) 2018. The patient also reported that since (b)(6) 2018, "sometimes when she gives herself a bolus it doesn't take away the pain. " the patient was redirected to inform her hcp about the discrepancies. No further complications were 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 Key7548899
MDR Text Key109455887
Report Number3004209178-2018-11993
Device Sequence Number1
Product Code LKK
UDI-Device Identifier00643169530119
UDI-Public00643169530119
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 consumer
Reporter Occupation
Type of Report Initial
Report Date 05/29/2018
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received05/29/2018
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date06/28/2019
Device Model Number8637-20
Device Catalogue Number8637-20
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? No
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received05/25/2018
Was Device Evaluated by Manufacturer? No Answer Provided
Date Device Manufactured01/03/2018
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: 05/29/2018 Patient Sequence Number: 1
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