MAUDE Adverse Event Report: MEDTRONIC PUERTO RICO OPERATIONS CO. SYNCHROMED II; PUMP, INFUSION, IMPLANTED, PROGRAMMABLE

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.

• Brand Name: SYNCHROMED II
• Type of Device: PUMP, 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 Key: 8298290
• MDR Text Key: 134779942
• Report Number: 3004209178-2019-02275
• Device Sequence Number: 1
• Product Code: LKK
• UDI-Device Identifier: 00643169630505
• UDI-Public: 00643169630505
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P860004
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Physician
• 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 Received: 02/01/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 03/28/2020
• Device Model Number: 8637-20
• Device Catalogue Number: 8637-20
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 02/21/2019
• Date Device Manufactured: 10/03/2018
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention