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

Model Number 8637-20

Device Problems Aspiration Issue (2883); Difficult to Advance (2920); Material Integrity Problem (2978)

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

Event Date 06/02/2017

Event Type  Injury  

Manufacturer Narrative

Other applicable components are: product id 8731sc lot# serial# (b)(4) implanted: (b)(6) 2012 product type catheter.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 healthcare provider via a company representative regarding a patient receiving an unknown drug via an implantable pump.The indication for use was non malignant pain and spinal stenosis.A possible catheter issue was reported.The environmental, external or patient factors that may have led or contributed to the issue it was reported that the patient had an un related chest x-ray and saw image, possible catheter disconnect.Diagnostics and or troubleshooting performed was a dye study was attempted, date unknown, but they were unable to aspirate.The actions and or interventions taken to resolve the issue was the patient would be scheduled for a catheter revision.The issue was not resolved at the time of the report and the patient status was noted as alive, no injury.No further patient complications have been reported as a result of this event.

Manufacturer Narrative

The main component of the system and other applicable components are: product id: neu_unknown_cath, serial# unknown, product type: catheter.If information is provided in the future, a supplemental report will be issued.

Event Description

Additional information was received and it was reported that the patient was taken to surgery on (b)(6) 2017 to revise the damaged catheter that was seen on x-ray.The revision was aborted secondary to being unable to advance the catheter.The spinal segment of the catheter was removed and the pump remained implanted.Per the reporter, the patient may be referred to a neurosurgeon.The issue was noted to be resolved at the time of the report and the patient status was reported as ¿alive ¿ no injury¿.No further patient complications have been reported as a result of this event.

Manufacturer Narrative

(b)(4).If information is provided in the future, a supplemental report will be issued.

Event Description

Additional information received reported that the cause for the inability to advance the catheter was unknown.The catheter was advanced about 1.5 vertebral bodies and couldn¿t advance further.It was unable to advance based on anatomical issues and no catheter issue was suspected.No further patient complications were reported.

Manufacturer Narrative

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): MDT PUERTO RICO OPERATIONS CO; rd 31 km 24 hm 4; juncos PR 00777
• Manufacturer (Section G): MDT PUERTO RICO OPERATIONS CO; rd 31 km 24 hm 4; juncos PR 00777
• Manufacturer Contact: lisa woodward clark ; 7000 central avenue ne rcw215; minneapolis, MN 55432 ; 7635263920
• MDR Report Key: 6610821
• MDR Text Key: 76641675
• Report Number: 3004209178-2017-11594
• Device Sequence Number: 1
• Product Code: LKK
• UDI-Device Identifier: 00613994779229
• UDI-Public: 00613994779229
• 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: 07/27/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/05/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 12/14/2013
• Device Model Number: 8637-20
• Device Catalogue Number: 8637-20
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 07/26/2017
• Date Device Manufactured: 06/14/2012
• 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: 77 YR