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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 Abdominal Pain (1685); Adhesion(s) (1695); Cellulitis (1768); Erythema (1840); Unspecified Infection (1930); Seroma (2069); Vomiting (2144); Swelling/ Edema (4577)
Event Date 10/16/2020
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 healthcare professional (hcp) via a clinical study regarding a patient receiving compounded baclofen (unknown dose and concentration) via an implantable pump. It was reported erythema and edema was noted over the pump site of unclear etiology. It was noted there did not seem to be any fluctuance, and did seem to be going into baclofen withdrawal to suggest that there was a problem with the pump. An ultrasound (us) demonstrated fluid collection and possible cellulitis on (b)(6) 2020. Device interrogation was normal on (b)(6) 2020. An x-ray revealed the pump and catheter appeared normal. On (b)(6) 2020 keflex was prescribed and extra office visits were scheduled to monitor. It was noted that given the patient's recent abdominal surgery in august, follow by abdominal pain and emesis post operatively, it was certainly possible that they have an infection that has seated into their pump pocket. The outcome of the event resolved with sequelae. The sequelae was noted as what seemed like adhesions on the lateral border of the pump, which were not painful. To palpation. The pump site itself was no longer red. The clinical diagnosis was cellulitis near the pump site. The event resulted in medical or surgical intervention to prevent life threatening illness or injury or permanent impairment to a body structure or body function. The etiology of the event indicated the relationship of the event to the device or therapy was unlikely related and indicated the relationship of the event to the implant procedure was not related. The incisional site/device tract was pump pocket. The event date was (b)(6) 2020.
 
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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
david gustafson
7000 central avenue ne rcw215
minneapolis, MN 55432
7635149628
MDR Report Key12474099
MDR Text Key271466786
Report Number3004209178-2021-13854
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 health professional,study
Reporter Occupation
Type of Report Initial,Followup
Report Date 09/20/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received09/15/2021
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Expiration Date12/28/2020
Device Model Number8637-40
Device Catalogue Number8637-40
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received09/17/2021
Was Device Evaluated by Manufacturer? No Answer Provided
Date Device Manufactured07/02/2019
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: 09/15/2021 Patient Sequence Number: 1
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