MAUDE Adverse Event Report: MEDTRONIC MED REL MEDTRONIC PUERTO RICO SYNERGY; STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR

Model Number 7427

Device Problem Difficult to Remove (1528)

Patient Problem Pain (1994)

Event Type  Injury  

Event Description

Caller reports the implantable neurostimulator (ins) was explanted on (b)(6) 2021 but the "intra epidural components of the leads" are still implanted because they were unable to remove them.Troubleshooting asked for reason ins was explanted - caller states a note from (b)(6) 2021 indicates that reason for explant was patient reported the ins does not work/was not effective and was causing him "sharp burning pain".Caller states this note also indicated the patient had the ins turned off for 10 years.

Manufacturer Narrative

Concomitant medical products: product id: 3998, lot#: j0546323v, implanted: (b)(6) 2005, product type: lead.The main component of the system.Other relevant device(s) are: product id: 3998, serial/lot #: (b)(4), ubd: 02-aug-2009, udi#: (b)(4).If information is provided in the future, a supplemental report will be issued.

• Brand Name: SYNERGY
• Type of Device: STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR
• Manufacturer (Section D): MEDTRONIC MED REL MEDTRONIC PUERTO RICO; road 31, km. 24, hm 4; ceiba norte industrial park; juncos PR 00777
• Manufacturer (Section G): MEDTRONIC MED REL MEDTRONIC PUERTO RICO; 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: 13022834
• MDR Text Key: 286638676
• Report Number: 3004209178-2021-18698
• Device Sequence Number: 1
• Product Code: LGW
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P840001
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 12/16/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 01/28/2007
• Device Model Number: 7427
• Device Catalogue Number: 7427
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 12/15/2021
• Initial Date FDA Received: 12/16/2021
• Date Device Manufactured: 08/08/2005
• 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 Sex: Male