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

Model Number 8637-20

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

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

Event Date 12/27/2018

Event Type  malfunction  

Manufacturer Narrative

Concomitant medical products: the main component of the system and other applicable components are: product id: 8780, serial#: (b)(4), product type: catheter.Other relevant device(s) are: product id: 8780, serial/lot #: (b)(4), ubd: 26-nov-2020, udi#: (b)(4).If information is provided in the future, a supplemental report will be issued.

Event Description

Information was received from a healthcare provider (hcp) via a manufacturer representative regarding a patient who was receiving prialt (25mcg/ml at 1.2mcg/day) via intrathecal drug delivery pump.The indication for use was not noted.It was reported that intra-operative on (b)(6) 2018, the hcp could not advance the catheter.The hcp was inserting the catheter, but could not see the tip on x-ray.There was resistance when trying to insert it and then the catheter was looping/coming down, so it was pulled all the way out of the body and it was discovered that the end of the catheter was bent, so they implanted a whole new one.No symptoms were reported.There were no further complications reported at this time.

Manufacturer Narrative

Analysis results were not available at the time of this report.A follow-up report will be sent when analysis is completed.(b)(4).If information is provided in the future, a supplemental report will be issued.

Event Description

Additional information was received from a hcp via a manufacturer representative.It was reported that the patient recovered without sequela.The reason for catheter removal was the bent tip and "poss.Perf." there were no further complications reported at this time.

Manufacturer Narrative

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

Event Description

Additional information was received from a manufacturer representative.It was reported that possible perforation was a concern from the physician since the catheter was bent.The hcp and manufacturer representative did not visually see any perforations at the bend in the catheter, it was just a concern.There were no further complications reported at this time.

Manufacturer Narrative

Analysis of the implantable catheter (serial # (b)(4)) identified a bend at the dispensing hole area and damage to the winding in the guide wire and catheter that is consistent with implant damage.Eval code-method 4118 no longer applies.Eval code-result 3233 no longer applies.Eval code-conclusion 11 no longer applies.Medtronic, inc.(medtronic) is submitting this report to comply with 21 c.F.R.Part 803, the medical device reporting regulation.This report is based upon information obtained by medtronic, which the company may not have been able to fully investigate or verify prior to the date the report was required by the fda.Medtronic has made reasonable efforts to obtain more complete information in the time allotted and has provided as much information as is available to the company as of the submission date this report.This report does not constitute an admission or a conclusion by fda, medtronic, or its employees that the device, medtronic or its employees caused or contributed to the event described in the report.In particular, this report does not constitute an admission by anyone that the product described in this report has any "defects" or has "malfunctioned".These words are included in the fda 3500a form and are fixed items for selection created by the fda, to categorize the type of event solely for the purpose of reporting pursuant to part 803.Medtronic objects to the use of these words and others like it because of the lack of definition and the connotations implied by these terms.This statement should be included with any information or report disclosed to the public under the freedom of information act.Any required fields that are unpopulated are blank because the information is currently unknown or unavailable.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.

• 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
• MDR Report Key: 8208970
• MDR Text Key: 131815407
• Report Number: 3004209178-2019-00052
• Device Sequence Number: 1
• Product Code: LKK
• UDI-Device Identifier: 00643169630505
• UDI-Public: 00643169630505
• Combination Product (y/n): N
• PMA/PMN Number: P860004
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Type of Report: Initial,Followup,Followup,Followup
• Report Date: 02/12/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/02/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 05/28/2020
• Device Model Number: 8637-20
• Device Catalogue Number: 8637-20
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/16/2019
• Date Manufacturer Received: 02/11/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 55 YR