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

Model Number 8637-20

Device Problems Disconnection (1171); Difficult to Interrogate (1331); Communication or Transmission Problem (2896); Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Abscess (1690); Seroma (2069); Swelling (2091); Therapeutic Response, Decreased (2271); Complaint, Ill-Defined (2331)

Event Date 01/10/2018

Event Type  Injury  

Manufacturer Narrative

Concomitant product(s): product id: 8780, serial# (b)(4), implanted: (b)(6) 2014, product type: catheter.Product id: 8780, serial# (b)(4), implanted: (b)(6) 2018, product type: catheter.Other relevant device(s) are: product id: 8780, serial/lot #: (b)(4), ubd: 06-mar-2016, udi#: (b)(4); product id: 8780, serial/lot #: (b)(4), ubd: 03-mar-2019, 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 an unknown drug via an implantable infusion pump.It was reported that about a week or so after a refill on (b)(6) 2018 the patient experienced what was described as a "tightening rope" in her abdomen area.It was noted that there was no pain or redness of the area.It was stated that the patient saw her healthcare provider (hcp)later that week on (b)(6) 2018 and did not mention the symptoms but on (b)(6) 2018 there was swelling noticed.There not reports of a fall or injury and no other reported environmental/external/patient factors that may have led or contributed to the issue.It was unknown if any x-rays were taken but the patient was scheduled for a catheter revision surgery on (b)(6) 2018.The issue remained unresolved.

Manufacturer Narrative

Review of additional information received shows that there is no information to reasonably suggest that the previously reported catheter model 8780 with sn (b)(4) may have caused or contributed to a death or serious injury or that the device had malfunctioned.Therefore, this device does not meet the reporting requirements stipulated in 21 cfr 803.If information is provided in the future, a supplemental report will be issued.

Event Description

Additional information was received from a healthcare provider (hcp) via a device manufacturer representative indicated that the patient experienced a return in pain.The serial number of the catheter that was involved in the revision.It was unknown what caused the catheter to be disconnected at the pump.It was reported that the swelling and fluid in the pocket was resolved during the revision surgery and there were no issues post revision.It was reported that the catheter was returned for analysis.The issue regarding the programmer showing the incorrect catheter volume was due to the device manufacturer representative's miscalculations and the issue was resolved.It was noted that the issue was resolved.No further 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 was received from a healthcare provider (hcp) via a company representative.The company representative indicated they were notified yesterday, the night of (b)(6) 2018, and she was helping cover the case.A catheter event had been confirmed.When they opened the pump pocket, there was about 2400 cc of fluid (seemed like abscess) in the pocket and it was very difficult to read the pump.The catheter was found to be disconnected from the pump as well for an unknown length of time.The company representatative indicated that as far as she knew, there was no dye study that was performed.The patient came in for a refill (b)(6) 2018 and there were no issues mentioned at that time.The company representative was calling for assistance with entering in the new catheter information.The programmer was currently showing 0.157 ml for the catheter volume; however, in the print report she created earlier today, it is showing a catheter volume of 0.159 ml.At the time of the report, they re-interrogated the pump.After re-interrogation, the reporter was seeing the catheter volume as 0.159 ml.The following information and catheter programming was reviewed at the time of the report: original catheter length: 27.9 cm (pump segment) + 44.3 cm (spinal segment) = 72.2 cm original cathetervolume: 72.2 cm x 0.0022 ml/cm = 0.159 ml new catheter length: 72.2 cm - 31 cm + 22.5 cm = 63.7 cm new catheter volume: 63.7 cm x 0.0022 ml/cm = 0.14 ml.They planned to send the back the portion of catheter explanted on (b)(6) 2018 to the manufacturer.No further patient symptoms were reported.The date of event was described as being sometime between the last pump revision in (b)(6) 2018.The date (b)(6) 2018 is considered an approximate date of event (year known only).Refer to mfr report # 3004209178-2017-18588 regarding prior pump and catheter revision/replacement performed on (b)(6) 2018.The hcp wanted the patient to go down to 0.1 mg/day, however programming would not allow that.The company representative was to review this with the hcp to determine what to program the patient to.The patient was described as typically having used a personal therapy manager (ptm), but they would be disabling that at this time.The pump was currently administering morphine with concentration 5 mg/ml at a dose rate of 0.3245 mg/day.The indication for use regarding the pump was spinal pain.Refer to (b)(4) for prior catheter revision/replacement on (b)(6) 2018; (b)(4).

Manufacturer Narrative

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.

Manufacturer Narrative

Correction: only adverse event was previously indicated in error and was updated in this report to indicate adverse event and product problem.If information is provided in the future, a supplemental report will be issued.

Manufacturer Narrative

Concomitant medical products: product id: neu_unknown_prog; product type: programmer; physician product id: 8780; lot#:serial#: (b)(4); implanted: on (b)(6) 2014; product type: catheter; product id: 8780; lot#: serial#: (b)(4); implanted: on (b)(6) 2018; explanted: on (b)(6) 2018; product type: catheter.The previous submitted report incorrectly named the catheter model and serial number of the device that had no information to reasonably suggest that it caused or contributed to a death or serious injury or malfunctioned.Cather model: 8780 with sn#: (b)(4) did not meet the reporting requirements stipulated in 21 cfr 803.Device evaluated by mfr: the catheter (sn#: (b)(4) was returned and analysis identified that the catheter was not fully seated onto the connector and the collet was locked in place.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.

• 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: 7544639
• MDR Text Key: 109261643
• Report Number: 3004209178-2018-11879
• Device Sequence Number: 1
• Product Code: LKK
• UDI-Device Identifier: 00643169530119
• UDI-Public: 00643169530119
• 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,consum
• Type of Report: Initial,Followup,Followup,Followup,Followup
• Report Date: 10/04/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/25/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 01/28/2019
• Device Model Number: 8637-20
• Device Catalogue Number: 8637-20
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 08/08/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 76 YR