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

Model Number 7427

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Unspecified Infection (1930); Swelling/ Edema (4577); Insufficient Information (4580)

Event Date 11/18/2011

Event Type  Injury  

Event Description

Information was received from a patient who was implanted with an implantable neurostimulator (ins) for myofacial pain syndrome.The reason for call was to get hcp listings to find hcp to remove the wires.Emailed.Pt reported they had so many problems with the device.It was removed in 2011.Pt reported they had problems with ins since day one.It did not work like they said it was going to work.When pt wanted to get it adjusted pt did not have anybody to go to.Pt just kept getting blownoff wherever they went.They did not take out the wires.The wires were behind the ear down the neck and down to abdomen to the ins.Pt reported this had been causing vagus nerve degeneration.Pt did not know it until recently.It caused a lot of infections.Infections started a year before they took out the ins, in 2010.Even where the ins was, about 3 years after they took the ins out, where the cavity was, there was a huge tumor.When they took the tumor out, it was not cancer.They said it looked like graphite.They took it out and it had not come back.But the wires had been getting all sorts of lumps all over them which was restricting even more.Even after 3 years of ins removal, pt kept their head shaved because of infections being so bad.One night pt swelled up and put a couple of pillow cases full of ice on their head for swelling to go down.Pt bent over and surgical putts came out off the top of my head.Pt went to hcp and they confirmed they were surgical putts.Pt just got out of the hospital with septic pneumonia and did not know that nerve was very important that controls a lot of your body.Pt also mentioned they had a scalp infection for 12 years.Pt mentioned they got very little support for the whole thing.Hcp who put the device in left the practice 3 months after implanted.Hcp who took ins out left that day.One hcp told pt that it would cost them more money and time to take wires out than pt's insurance would reimburse them for.Pt said they should have to go through all of this.Pt said it is probably going to take a plastic surgeon to remove the wires.Emailed pt hcp listings.Pt has no managing hcp.Dr (b)(6) put it in and dr.(b)(6) took it out.Redirected caller: patient's hcp.

Manufacturer Narrative

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: 14915018
• MDR Text Key: 295238969
• Report Number: 3004209178-2022-08416
• 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: Consumer
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 07/05/2022

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: 04/14/2007
• Device Model Number: 7427
• Device Catalogue Number: 7427
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 06/30/2022
• Initial Date FDA Received: 07/05/2022
• Date Device Manufactured: 10/26/2005
• 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 Age: 49 YR
• Patient Sex: Female