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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 Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problems Hypersensitivity/Allergic reaction (1907); Unspecified Infection (1930); Rash (2033); Seroma (2069)
Event Type  Injury  
Manufacturer Narrative
Concomitant medical products: product id: 8780, serial#: (b)(4), implanted: (b)(6) 2018, product type: catheter. Other relevant device(s) are: product id: 8780, serial/lot #: (b)(4), ubd: 14-aug-2020, udi#: (b)(4). If information is provided in the future, a supplemental report will be issued.
 
Event Description
Information was received from a health care provider (hcp) via a manufacturer representative regarding a patient who received an unknown drug in an implantable pump for non-malignant pain. The manufacturer representative received a text message from the hcp about a patient having an allergic reaction. It was unknown if the reaction was due to the drug, pump, or catheter. It was noted that at implant, the pump reservoir was filled with saline. The manufacturer representative was not sure if there was drug in the pump. Additional information received from a health care provider (hcp) indicated the initial presentation was abnormal rash that spread to the patient's back. The issue began on (b)(6) 2018. It was stated saline was in the pump at the time of the event. The patient was treated with antibiotics. The patient presented to a (b)(6) 2019 appointment following pump implantation complicated by an allergic reaction to an unknown allergen. The rash was stated to have resolved. Skin testing with adhesive and metallic samples were performed. The patient also experienced a small fluid collection around the catheter in the lumbar spine. There was no fever, chills, sweating, erythema, drainage, or tenderness. The patient denied spinal headache. The hcp believed the fluid collection to be benign with no evidence of infection. This may be a small cerebrospinal fluid collection. The patient would be monitored. The patient was to return in 1 week or send photo. No further information was provided.
 
Manufacturer Narrative
Concomitant medical products: product id: 8780, serial# (b)(4), implanted: (b)(6) 2018, product type: catheter is further reported in regulatory report # 3004209178-2019-03944. (see regulatory report # 3004209178-2019-03944). 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
lisa woodward clark
7000 central avenue ne rcw215
minneapolis, MN 55432
7635263920
MDR Report Key8298290
MDR Text Key134779942
Report Number3004209178-2019-02275
Device Sequence Number1
Product Code LKK
UDI-Device Identifier00643169630505
UDI-Public00643169630505
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 company representative,health
Reporter Occupation
Type of Report Initial,Followup
Report Date 02/25/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received02/01/2019
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Expiration Date03/28/2020
Device Model Number8637-20
Device Catalogue Number8637-20
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 Received02/21/2019
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

Patient Treatment Data
Date Received: 02/01/2019 Patient Sequence Number: 1
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