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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 Problem Pumping Stopped (1503)
Patient Problems Sleep Dysfunction (2517); Insufficient Information (4580)
Event Date 12/10/2021
Event Type  Injury  
Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.
 
Event Description
On b)(6) 2021, information was received from a patient receiving dilaudid (unknown dose and concentration) via an implantable pump for spinal pain. It was reported the patient had been going though withdrawals for 4-5 days. On the patient's 8835 ptm, they were getting code 8532 (stopped pump may exceed tube set). The patient stated they have gone to the emergency room two times due to withdrawals. The patient stated they could not function, their skin was crawling, could not sleep and could not "do anything". The patient thought they were having an anxiety attack and they even changed the patient's anxiety mediations. The patient's last refill was (b)(6) 2021. The patient has not had any mris recently. The patient stated they called their hcp and they have him coming in next week, thursday, to replace the pump. The patient then stated the pump alarmed about 4-5 days ago and has not alarmed for the last 1. 5 - 2 days that they could recall. End of service was reviewed with the patient. The patient stated their hcp told them they were still getting dilaudid even though the pump was not functioning. Troubleshooting was not required. The issue was not resolved as troubleshooting was not needed. The patient was redirected to their hcp to further address the issue.
 
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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 Key13022478
MDR Text Key287927508
Report Number3004209178-2021-18690
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 Non-Healthcare Professional
Type of Report Initial
Report Date 03/15/2022
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received12/16/2021
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date04/28/2016
Device Model Number8637-40
Device Catalogue Number8637-40
Was Device Available for Evaluation? No
Date Manufacturer Received03/10/2022
Was Device Evaluated by Manufacturer? No Answer Provided
Date Device Manufactured11/07/2014
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: 12/16/2021 Patient Sequence Number: 1
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