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

Model Number 8637-40

Device Problems Improper or Incorrect Procedure or Method (2017); Difficult to Advance (2920)

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

Event Date 06/05/2018

Event Type  malfunction  

Manufacturer Narrative

If information is provided in the future, a supplemental report will be issued.

Event Description

Information was received from a healthcare provider via a company representative regarding a patient who was receiving morphine with concentration 5.0 mg/ml at a dose rate of 0.5 mg/day via an implantable pump for malignant pain.It was reported that during the procedure the physician was threading the catheter to t10 and the catheter could not be advanced past t11.The physician pulled the needle and catheter out to try a different entry level.The physician pulled the stylet out of spinal segment to make sure there were no deformities.When the physician attempted to put stylet back inside the catheter it would not thread back in space.The styles appeared to be hitting an internal obstruction in the spinal section of the ascenda catheter.It was further clarified that the physician attempted multiple times to rethread the stylet and it would not go seat all the way.A new model 8780 catheter was opened and implanted successfully without incident.The customer was notified that the product should be returned.The suspect spinal section (model 8780) was never implanted was to be returned to the manufacturer.The patient was without injury.Regarding environmental/external/patient factors that may have led or contributed to the issue, regular implant usage and nothing abnormal was indicated.Other medications (oral, etc.) the patient was receiving at the time of the event was unable to be obtained.No patient symptom was reported.No further patient complications have been reported as a result of this event.

Manufacturer Narrative

Only the catheter was returned to the manufacturer on (b)(6) 2018.Analysis results were not available at the time of this report.A follow-up report will be sent when analysis is completed.If information is provided in the future, a supplemental report will be issued.

Event Description

Additional information was received from a healthcare provider via a company representative.Regarding the catheter having been unable to be advanced past t11 it was noted that the cause was never identified or determined.The company representative did not have the patient¿s medical history or weight available.

Manufacturer Narrative

Analysis of the catheter on (b)(6) 2018 revealed user related damage that occurred to the catheter body and/or guidewire during implant.If information is provided in the future, a supplemental report will be issued.

Manufacturer Narrative

If information is provided in the future, a supplemental report will be issued.

Event Description

Additional information was received via a healthcare provider.The patient¿s weight was provided.It was further indicated that patient¿s relevant medical history included a burst fracture t-12, two heart stents, lung cancer, kidney cancer, prostate cancer, and thoracic back pain.

• 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: 7582483
• MDR Text Key: 110873015
• Report Number: 3004209178-2018-12970
• Device Sequence Number: 1
• Product Code: LKK
• UDI-Device Identifier: 00643169530126
• UDI-Public: 00643169530126
• 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,Followup,Followup
• Report Date: 09/14/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/08/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 11/14/2019
• Device Model Number: 8637-40
• Device Catalogue Number: 8637-40
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/27/2018
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 09/11/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 05/16/2018
• 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 Age: 88 YR
• Patient Weight: 76