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

Model Number 8637-40

Device Problem Migration or Expulsion of Device (1395)

Patient Problem Pain (1994)

Event Date 07/25/2018

Event Type  malfunction  

Event Description

2022-apr-26 clinical r113336025-ae-131 (hcp, sdy): information was received from multiple sources (healthcare provider, clinical study) regarding a patient who was receiving compounded baclofen, hydromorphone, bupivacaine, and clonidine via an implantable pump for unknown indications for use.It was reported that examination, on (b)(6) 2018, revealed the pump was flipping within the pocket. the patient also reported difficulty activating ptm secondary to the pump flipping. the patient had decreased low back pain relief without being able to activate the ptm.No action taken, as the patient was not ready for surgical revision.On (b)(6) 2018, the patient had persistent difficulty activating the ptm secondary to pump position.No intervention was planned at this visit.The patient was examined, on (b)(6) 2018, and the patient denied difficulty activating the ptm and the pump was filled without any note of pump flipping or inversion.It was indicated the event was related to the device or therapy.The issue resolved without sequelae on (b)(6) 2018.

Manufacturer Narrative

Concomitant medical products: product id: 8835; serial#: (b)(4); product type: programmer, patient.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: glen belmer ; 7000 central avenue ne rcw215; minneapolis, MN 55432 ; 6122713209
• MDR Report Key: 14218995
• MDR Text Key: 290570551
• Report Number: 3004209178-2022-05306
• Device Sequence Number: 1
• Product Code: LKK
• UDI-Device Identifier: 00643169508156
• UDI-Public: 00643169508156
• 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: Study,Health Professional
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 04/27/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/27/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 05/28/2017
• 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: 04/26/2022
• Date Device Manufactured: 12/08/2015
• 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: 56 YR
• Patient Sex: Female
• Patient Weight: 87 KG