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

Model Number 8637-40

Device Problems Filling Problem (1233); Difficult to Interrogate (1331); Unstable (1667)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Type  Injury  

Manufacturer Narrative

Concomitant medical products: product id neu_unknown_cath, product type: catheter.(b)(4).

Event Description

Information was received from a consumer, via a company representative, regarding a patient who was receiving baclofen (450 mcg/ml) at 149.77 mcg/day and fentanyl (3000 mcg/ml) at 998.5 mcg/day (drug lot numbers were unable to be obtained) via an implantable pump.Indications for use included failed back surgery syndrome and spinal pain.Concomitant medications and medical history were unable to be obtained.On an unknown date, soon after pump replacement in 2014, the pump had flipped in the pocket.No patient symptoms were reported, but there was trouble interrogating and filling the pump.Diagnostic testing/troubleshooting included an x-ray, on an unknown date, in which the pump appeared to be flipped.According to the healthcare provider (hcp), possible causes of the event included limited space between the rib and hip bones, and unhealthy tissue.On (b)(6) 2015, the pump pocket was revised, a mesh pouch was added, and a space was created below the existing pocket to help secure the pump in place.Upon viewing the pump intraoperatively, the hcp corroborated that the pump seemed to have healed in the flipped position.As of 2015-07-21, the pump remained in service, the issue was resolved, and the patient's status was "alive - no injury.".

• 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 NEUROMODULATION; 7000 central avenue ne rcw215; minneapolis MN 55432
• Manufacturer Contact: diane wolf ; 7000 central avenue ne rcw215; minneapolis, MN 55432 ; 7635263987
• MDR Report Key: 4996677
• MDR Text Key: 22767950
• Report Number: 3004209178-2015-15886
• Device Sequence Number: 1
• Product Code: LKK
• 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
• Report Date: 07/21/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/12/2015
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 09/28/2015
• Device Model Number: 8637-40
• Device Catalogue Number: 8637-40
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 07/21/2015
• Date Device Manufactured: 04/09/2014
• 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: 00058 YR