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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 Erythema (1840); Hypersensitivity/Allergic reaction (1907); Unspecified Infection (1930); Rash (2033)
Event Date 12/15/2021
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 provider (hcp) via manufacturer representative (rep) regarding a patient who was receiving unknown drug via an implantable pump for unknown indications for use. It was reported that the rep received an email from a hcp asking about custom wrapped pumps for a patient that has historically tried to have an pump implanted but previously developed a rash which led to an infection. The rep only had the email details to go off of and no patient info was given. The rep asked about custom product as well as an article that the doctor had attached to the email with a case study and therefore tech services redirected to medical affairs.
 
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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 MN 00777
Manufacturer (Section G)
MEDTRONIC PUERTO RICO OPERATIONS CO.
road 31, km. 24, hm 4
ceiba norte industrial park
juncos,pr MN 00777
Manufacturer Contact
glen belmer
7000 central avenue ne rcw215
minneapolis, MN 55432
6122713209
MDR Report Key13977399
MDR Text Key288384672
Report Number2182207-2022-00559
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,Company Representative
Reporter Occupation Other Health Care Professional
Type of Report Initial,Followup
Report Date 05/31/2022
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received04/01/2022
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Model Number8637-40
Device Catalogue Number8637-40
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Date Manufacturer Received05/26/2022
Was Device Evaluated by Manufacturer? No Answer Provided
Date Device Manufactured03/01/2021
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: 04/01/2022 Patient Sequence Number: 1
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