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

Model Number 7427

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

Patient Problems Fever (1858); Muscle Weakness (1967); Pain (1994); Staphylococcus Aureus (2058); Malaise (2359)

Event Date 07/01/2008

Event Type  Injury  

Manufacturer Narrative

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

Manufacturer Narrative

A good faith effort will be made to obtain the applicable information relevant to the report. If information is provided in the future, a supplemental report will be issued.

Event Description

Information was received from a patient who was implanted with a neurostimulator for complex regional pain syndrome type i. It was reported that the patient had an infection at the spine and pocket of the spinal cord stimulation implant in (b)(6) of 2008. The patient had a fever of greater than 105 degrees fahrenheit and she was a very sick woman. This was a sudden onset of symptoms. They did blood work and she was told that she had a (b)(6). Intravenous antibiotics and oral antibiotics were given as interventions and there was a total system explant. All spinal cord stimulation therapy components were removed. Once the infection was gone, they re-implanted the spinal cord stimulation system. The only drug that the patient currently takes is ibuprofen.

Event Description

Additional information was received from a business partner on 2017-mar-09. Information regarding the patient having an infection at the spine and implant site, a fever of greater than 105 degrees fahrenheit, being very sick, having a staph infection that was diagnosed with blood work and treated with intravenous antibiotics and oral antibiotics which resulted in a device explant was re-reported. It was also reported that the patient experienced muscular weakness in their left arm in (b)(6) 2008. The patient¿s relevant history includes pain in their left arm and left leg, non-malignant pain, and reflect sympathetic dystrophy/causalgia-complex regional pain syndrome. On (b)(6) 2009, a new device was implanted after the infection was resolved. As of (b)(6) 2016, the only drug the patient took was ibuprofen of an unknown concentration, route, dose, and frequency of use. On (b)(6) 2017, the business partner learned that the patient was a white female with a medical history that included crps (complex regional pain syndrome) was of the left arm and left leg. The patient¿s concomitant products included: cymbalta (duloxetine hydrochloride) 60 md/day,lipitor (atorvastatin calcium) 80 mg/day, zetia (ezetimibe), asa (acetylsalicylic acid), oxycontin (oxycodone), neurontin(gabapentin) 300 mg 4x/day and niaspan er (niacin extended release), dates of therapy, routes, doses and frequency of use were not reported, when not indicated. No further complications were reported/are anticipated.

Manufacturer Narrative

A good faith effort will be made to obtain the applicable information relevant to the report. If information is provided in the future, a supplemental report will be issued.

Event Description

Additional information was received from the healthcare provider. It was reported that the patient had the device explanted (b)(6) years ago in 2008. It was noted that the explant had nothing to do with the pump or its function.

• Brand Name: SYNERGY
• Type of Device: STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF
• 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: lisa woodward clark ; 7000 central avenue ne rcw215; minneapolis, MN 55432 ; 7635263920
• MDR Report Key: 6185547
• MDR Text Key: 101896434
• Report Number: 3004209178-2016-26733
• 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,health professional

Reporter Occupation

• Type of Report: Initial,Followup,Followup,Followup
• Report Date: 05/09/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/19/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No

Device Operator

• Device Expiration Date: 08/28/2005
• Device Model Number: 7427
• Device Catalogue Number: 7427
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No

Was the Report Sent to FDA?

• Event Location: No Information
• Date Manufacturer Received: 04/17/2017
• Was Device Evaluated by Manufacturer?: No Answer Provided
• Date Device Manufactured: 03/03/2004
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial

Patient Treatment Data

Date Received: 12/19/2016 Patient Sequence Number: 1