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

Model Number 8637-40

Device Problem Insufficient Information (3190)

Patient Problems Fall (1848); Pain (1994); Tingling (2171); Therapeutic Response, Decreased (2271); Discomfort (2330); Injury (2348); Ambulation Difficulties (2544)

Event Date 07/12/2018

Event Type  Injury  

Manufacturer Narrative

Concomitant medical product: product id: 8780, serial# (b)(4), implanted: (b)(6) 2017, product type: catheter.Other relevant device(s) are: product id: 8780, serial/lot #: (b)(4), (b)(6), (b)(4).If information is provided in the future, a supplemental report will be issued.

Event Description

Information was received from a consumer and healthcare professional (hcp) via a company representative regarding a patient receiving morphine (25 mg/ml at 5.502 mg/day) via an implanted pump.The indication for pump use was non-malignant pain.On (b)(6) 2018 it was reported that the patient¿s infusion system was originally implanted for left leg sciatica and was helping.A month to 6 weeks ago the patient started having tingling in her toes.She then had pain in both legs and her left leg was ¿way worse¿.She couldn¿t stand, she had to lay to get comfortable.It got worse after a 6 hour car ride this weekend.On sunday ((b)(6) 2018), she fell and hit her head because she was unsteady on her legs.It was unknown if there were any environmental, external, or patient factors that may have led or contributed to the issue.On (b)(6) 2018, the patient was taken to surgery at which time the back incision was opened and they pulled the catheter down slightly.It was noted that it seemed to veer to the right.The issue was resolved at t he time of the report.The patient status was reported as ¿alive ¿ no injury¿.It was indicated that the hcp had no further information regarding the event.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: 7812448
• MDR Text Key: 118106078
• Report Number: 3004209178-2018-19087
• Device Sequence Number: 1
• Product Code: LKK
• UDI-Device Identifier: 00643169508156
• UDI-Public: 00643169508156
• 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: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 08/24/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 09/14/2018
• Device Model Number: 8637-40
• Device Catalogue Number: 8637-40
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 08/23/2018
• Initial Date FDA Received: 08/24/2018
• Date Device Manufactured: 03/18/2017
• 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: 66 YR