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

Model Number 8637-20

Device Problems Self-Activation or Keying (1557); Application Program Problem (2880); Protective Measures Problem (3015); Insufficient Information (3190)

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

Event Date 06/30/2018

Event Type  malfunction  

Manufacturer Narrative

Date of event is an estimate.Other relevant device(s) are: product id: 8835, lot# serial#: (b)(4), product type: programmer, patient.(b)(4).Occupation: non-healthcare professional.If information is provided in the future, a supplemental report will be issued.

Event Description

Information was received from a patient who was receiving bupivacaine and dilaudid at an unknown concentration and dose via intrathecal drug delivery pump for spinal pain.It was reported that the patient's personal therapy manger (ptm) did not have the correct refill date after the refill, "15 days ago." the ptm was denying the bolus.The ptm was firing by itself "5 days ago." the patient had some other issues and was going to the hospital to begin with, and didn't want to deal with the ptm.The patient may have some mris (magnetic resonance imaging) done.The pump was "firing off by itself" without the patient giving herself a bolus.There were no reported symptoms.No further complications were reported.

Manufacturer Narrative

If information is provided in the future, a supplemental report will be issued.

• 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 PUERTO RICO OPERATIONS CO.; road 31, km. 24, hm 4; ceiba norte industrial park; juncos PR 00777
• Manufacturer Contact: lisa woodward clark ; 7000 central avenue ne rcw215; minneapolis, MN 55432 ; 7635263920
• MDR Report Key: 7752597
• MDR Text Key: 116872849
• Report Number: 3004209178-2018-17422
• Device Sequence Number: 1
• Product Code: LKK
• UDI-Device Identifier: 00643169508149
• UDI-Public: 00643169508149
• 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,Followup
• Report Date: 10/05/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/06/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 09/28/2017
• Device Model Number: 8637-20
• Device Catalogue Number: 8637-20
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 08/08/2018
• Date Device Manufactured: 03/30/2016
• 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: 53 YR