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

Model Number 863720

Device Problems Failure To Service (1563); Device Displays Incorrect Message (2591); Application Program Problem (2880)

Patient Problems Pain (1994); Therapeutic Effects, Unexpected (2099); Therapeutic Response, Decreased (2271)

Event Type  malfunction  

Event Description

It was reported that the patient had missed a refill.An alarm was heard but had not been performed by telemetry.The patient had a change in therapeutic effect.The patient was low on medication.The low reservoir alarm was on (b)(6) 2015 and the critical alarm started sounding on (b)(6) 2015.Withdrawal symptoms were reported.The patient was experiencing increased pain.Additional information received reported the patient¿s withdrawal symptoms included worsening pain.The reported alarm was confirmed through telemetry.The alarm that occurred on (b)(6) 2015 was reported as a normal early replacement indicator (eri).A low reservoir alarm did not occur despite the programmed reservoir volume being above the programmed low reservoir alarm volume.It was initially reported that it was unknown if a low reservoir alarm occurred, however it was later noted that the low reservoir alarm was not erroneous.It was initially reported that it was unknown if the patient missed a refill, then it was reported the patient did not missed a refill, however later it was reported that the cause of the event was a missed refill.The event was attributed to the pump.The issue was reported to be a low reservoir.It was reported that an empty reservoir alarm occurred despite the programmed reservoir alarm volume being above zero volume suggesting an erroneous empty reservoir alarm.It was unknown if a pump reset occurred.A pump memory error (pme) did not occur.A stopped pump did not occur and the alarm did not occur after a motor stall.The pump was not exposed to freezing temperatures during shipping or storage.No troubleshooting, interventions or other actions were taken to mitigate or resolve the event.The patient recovered without permanent impairment.The pump was infusing dilaudid (hydromorphone) and morphine (unknown).

Manufacturer Narrative

Concomitant medical products: product id: 8731sc, serial# (b)(4), implanted: (b)(6) 2008, product type: catheter.Product id: 8840, product type: programmer, physician.(b)(4).

• 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: 4850288
• MDR Text Key: 16308482
• Report Number: 3004209178-2015-11741
• 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,Health Professional
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 05/22/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/17/2015
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 07/14/2009
• Device Model Number: 863720
• Device Catalogue Number: 863720
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 05/22/2015
• Date Device Manufactured: 01/23/2008
• 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: 00054 YR