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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 Filling Problem (1233); Migration or Expulsion of Device (1395)
Patient Problems Diarrhea (1811); Pain (1994); Ambulation Difficulties (2544)
Event Type  malfunction  
Event Description
Information was received from a consumer regarding a patient receiving dilaudid via an implanted pump. It was noted that the patient also took oral oxycodone. The indication for pump use was non-malignant pain. The patient reported being in a lot of pain. Per the patient, the hcp (healthcare provider) had a hard time with refills for a couple of months. The pump was moved from her stomach to her back (see manufacturer¿s report number 3004209178-2020-10581) because of that, but the hcp still struggled to ¿find the hole¿ at the last refill 1. 5 to 2 weeks ago. She got a refill about every month or so. She stated that following this last refill she felt like she was not getting the medication because she had been having severe pain and bad diarrhea. The pain was so bad that she ¿can¿t get up and the pain feels like shocks or stabbing¿. She mentioned that she felt like the pump may have moved, but the hcp told her that it couldn¿t. The patient was redirected to her hcp to discuss her symptoms and concerns. Additional information was received from the patient on (b)(6) 2022 and she stated that she saw her hcp the same day that she called in ((b)(6) 2022). She stated that she was still in pain and inquired about getting a ptm (personal therapy manager) and that her hcp told her that she could get one. How the ptm works was reviewed with the patient, and she was redirected to her hcp to have him order her one.
 
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 Key13977840
MDR Text Key288818066
Report Number3004209178-2022-04136
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 04/01/2022
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received04/01/2022
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date03/28/2020
Device Model Number8637-20
Device Catalogue Number8637-20
Was Device Available for Evaluation? No
Date Manufacturer Received03/28/2022
Was Device Evaluated by Manufacturer? No Answer Provided
Date Device Manufactured10/03/2018
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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