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); Insufficient Flow or Under Infusion (2182); Device Ingredient or Reagent Problem (2910); Difficult to Advance (2920); Infusion or Flow Problem (2964); Material Integrity Problem (2978); Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Pain (1994); Seroma (2069); Therapeutic Response, Decreased (2271); No Known Impact Or Consequence To Patient (2692)

Event Date 06/28/2019

Event Type  Injury  

Manufacturer Narrative

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 company representative regarding a patient who was receiving dilaudid with concentration 19 mg/ml at a dose rate of 9 mg/day and morphine with concentration 20 mg/ml at a dose rate of 7.6 mg/day via an implantable pump for non-malignant pain.It was reported that the patient came in for a pump refill today ((b)(6) 2019) and they had expected to pull back 3 ml and got back 7 ml.The fluid pulled from the reservoir looked cloudy and orange according to the hcp.The hcp noted it looked like there was bacteria in the fluid.They had run the fluid for testing but would not have the results for about a week.It was further noted that they used 60 ml of saline and flushed the pump¿s reservoir.It was unknown if the saline came back cloudy or had any particles.The patient was tested for any bacterial infection and it came back negative.Regarding if there were any anomalies with the previous refill, it was noted that a different hcp who was no longer with the clinic had refilled the pump and did not note any anomalies with the refill.The hcp was planning to explant the pump (b)(6) 2019.It was indicated that the patient did not have any symptoms.No further patient complications have been reported as a result of this event.

Manufacturer Narrative

Update/correction: intervention required as previously selected is no longer applicable.The type of reportable event is also downgraded from reportable serious injury to a reportable malfunction regarding information previously provided via follow-up report # 2.If information is provided in the future, a supplemental report will be issued.

Event Description

Additional information was received via a healthcare provider.Regarding the circumstances that led to the seroma, it was noted that saline was injected.Regarding if a pocket fill was confirmed / cause of the pocket fill, it was noted that it was of saline.Regarding the cause of the empty pump alarm, it was indicated that it was empty.

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.

Event Description

Additional information was received from an hcp on 2019-jul-02.It was reported that the saline was put into the pump because they were worried the patient had a pocket fill at the time.It was noted that the pump was alarming for low and empty reservoir.The rate had been set to a high flow rate of >8ml/day of saline which would have flushed the catheter and tubing very quickly.It also would have accounted for why the pump was already empty.No symptoms or medical issues were reported associated with the possible pocket fill or programming the pump afterward.

Manufacturer Narrative

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 from an hcp via a manufacturer representative on 2020-jan-03.It was reported that the patient had continued to experience increased pain and a lump on their side area right over the catheter since (b)(6) 2019.On (b)(6) 2020, the hcp was performing a catheter revision and the pump was being replaced as well as it was part of a field action.

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 on 2020-jan-29.It was reported that regarding the difficulty advancing the new catheter, the provider was unsure if patient anatomy was the problem or the catheter.The hcp was hoping to check the catheter for tears or leaks.

Manufacturer Narrative

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 cause of the volume discrepancy, the physician believed the fluid was being pulled from a seroma sitting on top of the pump.Regarding actions taken to resolve the issue, it was noted that the pump was left in the patient and the patient was then refilled the week after.The patient¿s weight at the time of the event was unknown.

Manufacturer Narrative

Section 'device' information refers to the main device.The other relevant components include: product id: 8780, lot/serial# (b)(4), product type: catheter, ubd: 2021-08-29, udi#: (b)(4).Product id: 8709, lot/serial# (b)(4), implanted: (b)(6) 2005, explanted: (b)(6) 2020, product type: catheter, ubd:2007-01-14, udi#: (b)(4).Product id: 8596sc, lot/serial# (b)(4), implanted: (b)(6) 2012, explanted: (b)(6) 2020, product type: catheter.Analysis results were not available at the time of this report.A follow-up report will be sent once analysis is complete.The evaluation codes have been updated (b)(4) for the pump, as well as product id: 8709, lot/serial# (b)(4) and product id: 8596sc, lot/serial# (b)(4).The following codes (b)(4) only apply to product id: 8780, s/n: (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 on 2020-jan-15.It was reported the device had been delivering 7.9 mg of morphine.It was indicated the device had been used with/in the patient for treatment.The rep reported the cause of the volume discrepancy was never determined.The rep reported the system was explanted on (b)(6) 2020.The patient had been scheduled for a catheter replacement.The patient was presenting with fluid in the pump pocket and along the catheter route.The doctor opened the pocket and found discolored fluid, which was sent for testing.The rep stated the results from the fluid testing were not available at this time, the clinic could not find them.The hcp tried to aspirate the catheter through the cap (catheter access port) and they were unable to do so.The doctor then cut the catheter in the spine and removed it.The doctor attempted to place a new 8780 catheter and could not get the needle past the vertebrae.Therefore, the decision was made to explant the pump.The system was not replaced.The pump and explanted catheters were returned to the manufacturer for analysis.It was indicated on the reason for the catheter removal was a "break, tear, hole" and due to the fluid in the pocket/along the catheter inside the patient.It was further noted the patient had complained of loss of therapy.It was reported the information provided had been confirmed by the physician/account.No further complications were reported or anticipated.

Manufacturer Narrative

Analysis of the pump identified a failure of laboratory dispense testing above specification.Analysis of the 8709 catheter (serial# (b)(4)) identified a hole in the catheter body that was not user related.Analysis of the 8596sc catheter (serial# (b)(4)) identified coring/tears/cuts in the seal of the catheter which met leak criteria.The previously reported evaluation conclusion, method, and result codes no longer apply.(b)(4).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: 8754545
• MDR Text Key: 149831259
• Report Number: 3004209178-2019-12813
• Device Sequence Number: 1
• Product Code: LKK
• UDI-Device Identifier: 00643169630512
• UDI-Public: 00643169630512
• 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
• Remedial Action: Notification
• Type of Report: Initial,Followup,Followup,Followup,Followup
• Report Date: 03/18/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 06/28/2020
• Device Model Number: 8637-40
• Device Catalogue Number: 8637-40
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/28/2020
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 06/28/2019
• Initial Date FDA Received: 07/02/2019
• Supplement Dates Manufacturer Received: 07/02/2019; 07/12/2019; 07/12/2019; 07/18/2019; 01/03/2020; 01/15/2020; 01/29/2020; 03/11/2020
• Supplement Dates FDA Received: 07/03/2019; 07/18/2019; 07/23/2019; 07/26/2019; 01/14/2020; 01/29/2020; 02/14/2020; 03/18/2020
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 01/03/2019
• 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-1060-2011
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 58 YR