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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 Problems Failure To Service (1563); Device Displays Incorrect Message (2591)
Patient Problems Pain (1994); Therapeutic Effects, Unexpected (2099)
Event Type  malfunction  
Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.
 
Event Description
On (b)(6) 2018, information was received from a patient receiving hydromorphone (15. 0 mg/ml, 1. 650 mg/day), bupivacaine (10. 0 mg/ml, 1. 100 mg/day) and morphine (25. 0 mg/ml, 2. 750 mg/day) via an implantable pump for non-malignant pain. Beginning a couple months ago in 2018, the patient was in a rehabilitation facility and they wouldn¿t allow the patient to get their pump filled. The alarm went off and the "facility didn't care". The alarm started out as the single tone alarm and then it got louder and turned into a dual alarm. The patient then stated their pump ran dry. Additional details stated the pump was refilled and it was dry. The patient also stated that the pump was about half full. The patient reported that they had been putting in a little bit of medication at a time. The patient said it was extremely painful and they didn't understand why it wasn¿t working. The patient said they needed to be increased 25%. The patient also said they needed to get the pump filled all the way. The patient was in extreme pain. The patient indicated they took oral medication and they didn¿t have that either. The patient took tamazapan for their neuropathy pain and stated they were running out of medication. The patient then indicated they had moved because they could get better care. The patient indicated they went to the hospital about 10 days ago and they gave her a one-time refill of oral medications. They also gave the patient a referral for a primary care healthcare professional (hcp). The patient had an appointment for (b)(6). The patient's pain was indicated as gradual as it would start in the morning and was getting worse. The patient said "the pain is getting worse" and they didn¿t think they could make it.
 
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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 Key7565643
MDR Text Key110044675
Report Number3004209178-2018-12480
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 consumer
Reporter Occupation
Type of Report Initial
Report Date 06/04/2018
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received06/04/2018
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date08/28/2015
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 Received05/30/2018
Was Device Evaluated by Manufacturer? No Answer Provided
Date Device Manufactured03/04/2014
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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