MAUDE Adverse Event Report: MEDTRONIC NEUROMODULATION SYNCHROMED II; PUMP, INFUSION, IMPLANTED, PROGRAMMABLE

Model Number 863740

Device Problems Difficult to Interrogate (1331); Device Displays Incorrect Message (2591)

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

Event Type  malfunction  

Event Description

It was reported that there was a suspected antenna issue.It was very difficult to interrogate the pump per the patient and healthcare providers.Patient¿s status at the time of report was ¿alive-no injury.¿ there were no patient symptoms or complications associated with the event.It was reported that there was never any disruption to therapy or any adverse events for the patient.It was further noted that ¿it was more a general issue about the connection when interrogating the pump.¿ it was reported that the pump was explanted and replaced.It was reported that the pump system was delivering gablofen.Additional information reported that telemetry issue only involved the physician programmer and the manufacture representative¿s ¿personal clinician programmer as well.¿ it was reported that upon interrogation the status bar would only go to about 75% and stall out.The manufacture representative had been warned about the possibility of that happening prior to the interrogation by the nurse that does the patient's regular scheduled refills.The patient also stated this happened most of the time but ultimately it had always been able to be completed.It was reported that the manufacture representative personally cancelled the interrogation, repositioned and restarted the process.It was reported that the cause was ¿possible antenna issue.¿ it was further stated that the patient was doing well, no issues reported.It was reported that the patient was explanted and re-implanted due to an ¿eri¿ (elective replacement indicator).

Manufacturer Narrative

Concomitant products: product id: 8709, serial# (b)(4), implanted: (b)(6) 2007, product type: catheter.Product id: 8840, serial# unknown, product type: programmer, physician.(b)(4).

• Brand Name: SYNCHROMED II
• Type of Device: PUMP, INFUSION, IMPLANTED, PROGRAMMABLE
• Manufacturer (Section D): MEDTRONIC NEUROMODULATION; 800 53rd ave ne; minneapolis MN 55421 120
• 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: 3629626
• MDR Text Key: 3985358
• Report Number: 3007566237-2014-00480
• 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: 02/12/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/14/2014
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 11/14/2008
• Device Model Number: 863740
• Device Catalogue Number: 863740
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/17/2014
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 02/12/2014
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 05/23/2007
• 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