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 Abdominal Pain (1685); Unspecified Infection (1930); Pain (1994); Swelling (2091)

Event Date 05/03/2017

Event Type  Injury  

Manufacturer Narrative

Other relevant components include: product id 8780 lot# serial# (b)(4) implanted: (b)(6) 2016 explanted: (b)(6) 2017 product type catheter.(b)(4).A good faith effort will be made to obtain the applicable information relevant to the report.If information is provided in the future, a supplemental report will be issued.

Event Description

Information was received from a consumer via manufacturer representative regarding a patient receiving morphine 2mg/ml for a total dose of 0.2001mg/day via an implantable pump for non-malignant pain.It was reported the patient had an increase in post implant pain and swelling.The patient had a computed tomography (ct) scan, a catheter dye study, and was seen in the emergency room (er) a couple of times regarding pain in abdominal area.The pump and catheter were explanted on (b)(6) 2017 and will not be returned for analysis.Cultures of pump pocket site were sent to pathology.Surgical intervention occurred as the patient was seen in the er on (b)(6) 2017 for possible pump site infection.The patient was discharged and referred to neurosurgery for a pocket revision.Upon opening the pump pocket site, it was noted that the patient had an active infection and the decision was made to completely explant both the pump and the catheter.It was noted that the issue was resolved at time of report, and the patient's status at time of report was "alive-no injury." the patient's weight was 103kg.The patient's medical history was asked, but unknown.Event date was (b)(6) 2017.No further complications were reported/anticipated.

• 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: 6797206
• MDR Text Key: 82783516
• Report Number: 3004209178-2017-17537
• Device Sequence Number: 1
• Product Code: LKK
• UDI-Device Identifier: 00643169508149
• UDI-Public: 00643169508149
• 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,consum
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 08/16/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/16/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 03/14/2018
• Device Model Number: 8637-20
• Device Catalogue Number: 8637-20
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 06/20/2017
• Date Device Manufactured: 09/15/2016
• 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
• Patient Age: 45 YR
• Patient Weight: 103