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

Model Number 8637-40

Device Problems Electromagnetic Interference (1194); Filling Problem (1233); Difficult to Interrogate (1331); Device Displays Incorrect Message (2591)

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

Event Type  malfunction  

Manufacturer Narrative

Concomitant products: product id 8709, lot # l73871, implanted: (b)(6) 1999, product type catheter; product id 8835, serial # (b)(4), product type programmer, patient; product id 8578, serial # (b)(4), implanted: (b)(6) 2012, product type accessory; product id 8840, serial # unknown, product type programmer, physician.(b)(4).

Event Description

Information was received from a consumer regarding a patient receiving dilaudid (5.0 mg/ml at 1.1766 mg/day) and marcaine (5 mg/ml at 1.1766 mg/day) via an implanted pump.The indication for pump use was non-malignant pain.On (b)(6) 2014, it was reported that in (b)(6) 2014, the patient was jolted by/got struck by lightning.Per the patient, the lightning was so intense that it blew out the apartment cable; she was shocked by the lightning, but didn't fall unconscious from it.The patient wanted to know what affect lightning could have on the pump.Two weeks after the event, the clinician had a hard time getting communication going with the pump and the 8840 programmer; it took almost 45 minutes to complete.They thought the pump had flipped over because the programmer kept shutting off.They did an ultrasound and it showed that it was not flipped.The clinician also had a hard time finding the pump for a refill.Within the last two weeks, the last couple of times the patient tried to use her ptm (personal therapy manager), she had had issues with it communicating with the pump.Twice, when she went to give herself a bolus, it gave her a strange reading.She turned the ptm off and then back on and then it worked fine.The patient didn't have any details about the funny screen.The patient was using alkaline batteries in the ptm.She had an appointment to go back to the doctor in two weeks to get the pump refilled.The patient symptoms related the events, troubleshooting, actions/interventions, the cause of the events, and resolution of the events was not reported.Further follow-up was conducted to obtain this information.If additional information is received, a follow-up report will be sent.

• Brand Name: SYNCHROMED II
• Type of Device: PUMP, INFUSION, IMPLANTED, PROGRAMMABLE
• Manufacturer (Section D): MDT PUERTO RICO OPERATIONS CO; rd 31 km 24 hm 4; 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: 5273394
• MDR Text Key: 33343020
• Report Number: 3004209178-2015-23954
• 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: consumer
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 12/31/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/08/2015
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 09/28/2013
• Device Model Number: 8637-40
• Device Catalogue Number: 8637-40
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 12/31/2014
• Date Device Manufactured: 03/28/2012
• 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: 00058 YR