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

Model Number 8637-40

Device Problems Device Or Device Fragments Location Unknown (2590); Material Integrity Problem (2978)

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

Event Type  Injury  

Manufacturer Narrative

Concomitant medical products: product id: 8781, serial#: (b)(4), implanted: (b)(6) 2014, product type: catheter.Other relevant device(s) are: product id: 8781, serial/lot #: (b)(4), ubd: 03-sep-2016, udi#: (b)(4).If information is provided in the future, a supplemental report will be issued.

Event Description

Information was received from a consumer via a device manufacturer representative regarding a patient receiving saline (1 mg/ml at 0.048 mg/day) via an implantable infusion pump.The indications for use were noted to be non-malignant pain and post lumbar laminectomy syndrome.The patient's medical history included sleep apnea, panic disorder, spinal stenosis, adhd, restless leg syndrome and vitamin d deficiency.It was reported that the patient was having an elective pump removal as he no longer needed the pump.During the surgery, it was noted that the catheter looked damaged near the pump.It was also noted the catheter looked "very odd" and the representative stated it was difficult to try to explain.A catheter shear was also noted.Approximately 6-7 cm of the catheter was left attached to the pump.The remaining catheter was left implanted and was tied off in the pocket.The catheter would be returned to the manufacturer per the doctor's wishes.There were no environmental, external or patient factors which may have led or contributed to the issue.No diagnostics or troubleshooting steps were performed.The issue was considered resolved.No patient symptoms were reported.The patient's status at the time of the report was alive - no injury.No further complications were reported.

Manufacturer Narrative

Continuation of d11: product id 8781 lot# serial# (b)(4)implanted: 2014(b)(6) explanted: product type catheter h3: analysis found damage to the ascenda transition tube.Analysis also found overinfusion due to an undetermined root cause.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: 7645195
• MDR Text Key: 112566884
• Report Number: 3004209178-2018-14530
• Device Sequence Number: 1
• Product Code: LKK
• UDI-Device Identifier: 00643169100824
• UDI-Public: 00643169100824
• 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
• Remedial Action: Recall
• Type of Report: Initial,Followup
• Report Date: 09/07/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/28/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 04/28/2016
• Device Model Number: 8637-40
• Device Catalogue Number: 8637-40
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/29/2018
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 09/06/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 11/03/2014
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Removal/Correction Number: Z-1570-2014
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Weight: 132