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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 Adverse Event Without Identified Device or Use Problem (2993)
Patient Problems Pain (1994); Ambulation Difficulties (2544)
Event Date 08/25/2016
Event Type  Injury  
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 clonidine and morphine via an implanted pump. The patient¿s concomitant medication included 3 percocet which she had taken for years. The indication for pump use was non-malignant pain. On (b)(6) 2020, the patient reported that she saw her hcp (healthcare provider) on (b)(6) 2020 because her pump was being titrated down because she wanted it removed. She wanted it removed because it was painful to have the pump implanted. Since implant, it was resting on her hip. The pain got better when she gained weight. She stated that she had just gotten out of the hospital, and she had been going through withdrawal since her last appointment with her hcp on (b)(6) 2020. Her pump had been titrated down as far as it could go. She also stated that she had lost (b)(6) pounds. The patient was redirected to her hcp about scheduling the explant procedure. Additional information was received on 23-feb-2022 from the patient who reported that she had the pump and catheter electively explanted. She stated that she had the pump removed because it rested between her hip and her ribcage, and it was painful. She also stated she would barely walk and about 6 months after implant she could barely walk. Per the patient, she decided that the trouble she was having with the pump and medication side effects outweighed the good pain relief she had been experiencing so she requested to have the pump removed.
 
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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 Key13619542
MDR Text Key286244228
Report Number3004209178-2022-02570
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 02/28/2022
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received02/28/2022
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Expiration Date11/14/2017
Device Model Number8637-40
Device Catalogue Number8637-40
Was Device Available for Evaluation? No
Date Manufacturer Received02/23/2022
Was Device Evaluated by Manufacturer? No Answer Provided
Date Device Manufactured05/18/2016
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: 02/28/2022 Patient Sequence Number: 1
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