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

Model Number 8637-20

Device Problems Difficult to Interrogate (1331); Volume Accuracy Problem (1675)

Patient Problems Foreign Body Reaction (1868); Seroma (2069); Therapeutic Effects, Unexpected (2099)

Event Date 07/14/2014

Event Type  malfunction  

Event Description

It was reported the patient never had therapeutic effect since implanted even after an increased dose.A dye study was performed which showed no issues.A bolus was given to the patient by the personal therapy manager (ptm), but there was no response to the bolus.There had been a ¿really large bulge¿ around the catheter, but it had since gone down.The patient also had a seroma around the pump pocket.They had a hard time getting telemetry to program the pump.The pump was used to deliver dilaudid.It was unclear what the ¿really large bulge¿ around the catheter was and follow-up has been requested to clarify.No intervention or outcome were reported.

Manufacturer Narrative

Concomitant medical products: product id 8780, serial# (b)(4), implanted: (b)(6) 2014, product type: catheter; product id 8780, serial# (b)(4), implanted: (b)(6) 2014, product type: catheter.(b)(4).

Event Description

It was later reported that since implant both the clinician programmer and personal therapy manager (ptm) had a hard/difficult time communicating with the pump.It would take a while for the clinician programmer to communicate with the pump.It was noted that an error code 0617 occurred.The patient was of average build and the pump was very superficial.The hcp had no issues attempting to interrogate with the clinician programmer and ptm while a manufacturer¿s representative was present in the health care professional¿s office.It was mentioned that the patient was frustrated.It was reported that during initial interrogation the patient did not want to lift their shirt.Once the patient lifted their shirt, 1 inch of fluid was noticed over the pump.There was also fluid at the spine where the catheter is located.It was noted as a decent amount of fluid at the spinal incision, at least a golf ball sized lump if not larger.The entire pocket was full of fluid.The fluid in the pocket did not have an appearance of infection.It was noted that the hcp had previously pulled fluid out of the pocket on (b)(6) and they were waiting for results.The hcp was planning to aspirate the fluid to assess.Additional information received reported that there was concern that the patient wasn¿t getting medication.At the time of report, they felt the patient¿s dose was just too low.The event was attributed to low dosing without enough oral medication taken.It was later clarified that the large bulge around the catheter was a seroma.No infection per culture.It was noted that they felt that the patient¿s body does not like device.A dye study showed no problem.The patient recovered without permanent impairment.The patient had on-going pain and they were continuing to increase dose.It was later reported by a manufacturer¿s representative that the pump was used to infuse fentanyl.Volume discrepancy was checked at the patient¿s refill and was noted as not a significant discrepancy.No actual volumes were provided.The pump had been filled 2-3 times since implant.

Manufacturer Narrative

Concomitant product: product id 8835, serial # (b)(4), product type programmer, patient.(b)(4).

• 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 NEUROMODULATION; 7000 central avenue ne rcw215; minneapolis MN 55432
• Manufacturer Contact: diane wolf ; 7000 central avenue ne rcw215; minneapolis, MN 55432 ; 7635263987
• MDR Report Key: 4073170
• MDR Text Key: 4829735
• Report Number: 3004209178-2014-16629
• Device Sequence Number: 1
• Product Code: LKK
• 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: Health Professional
• Reporter Occupation: Health Professional
• Type of Report: Initial,Followup
• Report Date: 08/15/2014

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: 12/14/2015
• Device Model Number: 8637-20
• Device Catalogue Number: 8637-20
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 09/09/2014
• Initial Date FDA Received: 09/09/2014
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 09/19/2014
• Date Device Manufactured: 06/17/2014
• 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: 00050 YR