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

Model Number 8637-40

Device Problems Device Alarm System (1012); Nonstandard Device (1420); Application Program Problem (2880)

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

Event Type  malfunction  

Event Description

It was reported that an alarm was heard, but telemetry did not confirm an alarm.The alarm was due to a low reservoir.It was noted that the patient had not missed a refill.An erroneous low reservoir was noted.The low reservoir alarm occurred despite the programmed reservoir volume being above the programmed low reservoir alarm.The patient did not experience any symptoms related to this event.The non-critical alarm was played for the patient and daughter for verification.The logs verified for no indication of alarm.The patient had recovered without permanent impairment.The pump was infusing hydromorphone, clonidine, and bupivacaine.A follow-up report will be submitted if more information becomes available.

Manufacturer Narrative

Concomitant products: product id: 8870, product type: software.Product id: 8731sc, serial# (b)(4), implanted: (b)(6) 2015, product type: catheter.Product id: 8835, serial# (b)(4), product type: programmer, patient.Product id: 8596sc, serial# (b)(4), implanted: (b)(6) 2015, product type: catheter.(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: 4875968
• MDR Text Key: 5864724
• Report Number: 3004209178-2015-12430
• 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: Nurse
• Remedial Action: Recall
• Type of Report: Initial
• Report Date: 06/08/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/29/2015
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 09/28/2016
• 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: 06/08/2015
• Date Device Manufactured: 04/09/2015
• 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: 00060 YR