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

Model Number 8637-20

Device Problems Difficult to Interrogate (1331); Unstable (1667)

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

Event Type  Injury  

Manufacturer Narrative

Concomitant medical products: product id 8835, serial# (b)(4), product type: programmer, patient; product id 8835, serial# (b)(4), product type: programmer, patient; product id 8780, serial# (b)(4), implanted: (b)(6) 2014, product type: catheter.(b)(4).

Event Description

Information was received from a healthcare provider (hcp) and a company representative regarding a patient receiving intrathecal morphine (concentration 10mg/ml; dose 2.924mg/day) and bupivacaine (concentration 5mg/ml; dose 1.4622mg/day) via an implantable infusion pump.Indication for use was non-malignant pain and chronic low back pain.On an unknown date, the patient's pump began moving around and all of the sutures had broken loose.Per the hcp, the patient had extra subcutaneous tissue and skin was pulling on the pump.Due the pump moving, the patient had difficulty establishing communication with the pump via the personal therapy manager (ptm).It was unknown when this began.The patient experienced bolus unexpectedly declined and was having difficulty getting boluses to complete.The technical reported showed multiple times where it took a number of requests before the bolus finally went through.The patient used an external antenna.On (b)(6) 2015 the patient's pump pocket was revised and the pump was sutured down better.It was unknown if the ptm lockouts were resolved.The company representative downloaded the logs and observed the patient performing the bolus procedure with the ptm.There were no patient symptoms.Patient outcome was not provided.Additional information has been requested but was not available at the time of this report.

Event Description

Additional information was received from a company representative.The exact date of the ptm lockouts/denied boluses was unknown.The patient reported the issue at a visit on (b)(6) 2015.As of (b)(6) 2015, there were no further reports from the patient, so it was assumed that the ptm was working correctly.A new ptm had been sent to the patient.On (b)(6) 2015, it was reported that the patient was still stating that she was having ongoing ptm issues.The patient now stated that the refill date was going up even though she was using all of her boluses.The representative confirmed that the patient was not using all of her boluses so the refill date appeared to be increasing as expected.The patient also thought at one point that replacing the batteries erased the logs in the ptm as one time the patient claimed there were only 2 days of logs showing, but even though the patient changed the batteries regularly, the logs appeared to be showing normally.

• 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: 5251983
• MDR Text Key: 32196345
• Report Number: 3004209178-2015-23485
• 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: company representative,health
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 11/05/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/25/2015
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 09/14/2015
• Device Model Number: 8637-20
• Device Catalogue Number: 8637-20
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 12/01/2015
• Date Device Manufactured: 03/20/2014
• 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): Required Intervention
• Patient Age: 00041 YR