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

Model Number 8637-40

Device Problem Difficult to Interrogate (1331)

Patient Problem Overdose (1988)

Event Date 05/06/2014

Event Type  Injury  

Event Description

It was reported post-operatively a priming bolus error occurred.The physician was asked if he cleared the catheter and he stated he did and that it was dripping.It was noted in recovery, the patient went through programming with the physician assistant (pa) and she did not say anything about the external catheter not being cleared and she programmed the pump at 0930.It was further reported at 1430 on the date of this report the pa called saying the patient was in overdose and the physician in fact did not clear the catheter and only let it drip a couple of times.As a result, the patient was hospitalized and reprogrammed.It was unknown if diagnostic testing or troubleshooting was performed.It was also reported the patient was transferred to the emergency room (er) and the pump was decreased to minimum rate.It was noted the pa tried to aspirate the pump and cerebrospinal fluid (csf) and the patient¿s respiratory function was monitored.The patient was also having symptoms of overdose and was unresponsive.The pump was being used to deliver lioresal.It was further reported during the implant procedure for normal battery depletion they were unable to aspirate the reservoir completely and were only able to aspirate 19 milliliters (ml) with no difficulty from a 40 ml pump.It was noted they had accessed the pump several times and she only had the one pump.The healthcare provider (hcp) had tried holding negative pressure, but had no success and then confirmed the needle was bent and another pump was in transit.The hcp wanted to use a different pump due to the issues they were having.It was then reported, following a ¿warm bath¿ which released the pump the hcp was able to aspirate the reservoir fully and also able to inject the reservoir fully so that pump was implanted.It was reported on (b)(6) 2014 the patient was alert, following commands and had been extubated.It was noted the baclofen pump would be restarted at the patient¿s previous dose of 274 mcg/day.Additional information received reported the pump was replaced on (b)(6) 2014 due to normal battery depletion and an overdose occurred as a result of an error of the priming bolus at pump replacement surgery.It was also reported the long term facility where the patient resides was called to pick the patient up after surgery and when they got to the hospital the ¿blood pressure was way down,¿ but they said he was okay enough.It was noted by the time the patient got back to the facility he started going unresponsive and was placed on a respirator, and went into full distress.It was also reported, ¿at one point the neuro surgery place said to place a tko¿ and they stopped the pump for a day and turned it back on when the patient started coming back.It was further reported the patient was okay now and back to the facility, but at the time this was happening the healthcare provider (hcp) was having trouble even reading the pump.Additional information has been requested; a follow-up report will be sent when it becomes available.

Manufacturer Narrative

Concomitant medical products: product id neu_unknown_cath, serial# unknown, product type: catheter; product id neu_refillkit_acc, serial# neu_refillkit_acc, product type: accessory.(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: 3833559
• MDR Text Key: 4397425
• Report Number: 3004209178-2014-09645
• 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,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 05/06/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/27/2014
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 10/14/2015
• Device Model Number: 8637-40
• Device Catalogue Number: 8637-40
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 05/06/2014
• Date Device Manufactured: 04/23/2014
• 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 Outcome(s): Hospitalization; Life Threatening; Required Intervention