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

Model Number 8637-40

Device Problem Unstable (1667)

Patient Problems Fall (1848); Pain (1994); Therapeutic Response, Decreased (2271); Loss of consciousness (2418)

Event Date 07/01/2017

Event Type  Injury  

Event Description

Information was received from a consumer regarding a patient who was receiving dilaudid at an unknown dose and concentration via an implantable pump for spinal pain.It was reported that the patient had a return of back pain since (b)(6).Then "last week", the patient passed out in her driveway and fell on her face.It was also noted that (b)(6) was "bad for pain" and that the pump was moving in the pocket since (b)(6).Additionally, the patient had been seeing a poor communication error message on her personal therapy manager (ptm) since (b)(6) 2017.However, the patient was able to deliver a bolus after she changed the aaa alkaline batteries in her ptm.It was also stated that the patient did not have a physician and she would need her pump filled on (b)(6) 2017.No further complications were reported or anticipated.

• 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): MDT PUERTO RICO OPERATIONS CO; rd 31 km 24 hm 4; juncos PR 00777
• Manufacturer Contact: lisa woodward clark ; 7000 central avenue ne rcw215; minneapolis, MN 55432 ; 7635263920
• MDR Report Key: 6960970
• MDR Text Key: 89692150
• Report Number: 3004209178-2017-22106
• Device Sequence Number: 1
• Product Code: LKK
• UDI-Device Identifier: 00643169100824
• UDI-Public: 00643169100824
• 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
• Report Date: 10/19/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/19/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 05/28/2015
• Device Model Number: 8637-40
• Device Catalogue Number: 8637-40
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 09/21/2017
• Date Device Manufactured: 12/11/2013
• 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): Other
• Patient Age: 51 YR