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

Model Number 37714

Device Problems Unstable (1667); Battery Problem (2885); Charging Problem (2892)

Patient Problems Burn(s) (1757); Pain (1994); Pocket Erosion (2013); Skin Irritation (2076); Burning Sensation (2146); Therapeutic Response, Decreased (2271); Injury (2348)

Event Date 05/25/2016

Event Type  malfunction  

Manufacturer Narrative

Concomitant medical products: product id 37713, serial# (b)(4), implanted: (b)(6) 2011, explanted: (b)(6) 2013, product type: implantable neurostimulator.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

The patient and a healthcare provider reported that the patient had a burn mark over their implantable neurostimulator (ins) pocket on their abdomen and the skin was coming apart.The patient was wondering if they should go to the emergency room or wait for their upcoming doctor¿s appointment.Their ins had been hurting for a while and would flip in the pocket even though it had been anchored down.They were able to turn the ins so it was vertical.It was noted that the patient had lost a lot of weight and planned to keep losing weight.The burning and ins flipping started in (b)(6) 2015.Their ins had depleted and the patient was unable to charge due to the irritated skin.Due to the depletion the patient did not have therapy.They were experiencing burning and pain symptoms.After the patient met with their doctor they turned the ins off for 1 week.It was noted that the issues were likely due to a superficial injury as the device was functioning properly.The patient was implanted for non-malignant pain and complex regional pain syndrome.

Manufacturer Narrative

Corrected information: sex, date of birth.If information is provided in the future, a supplemental report will be issued.

• Brand Name: RESTORE SENSOR
• Type of Device: STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF
• Manufacturer (Section D): MEDTRONIC MED REL MEDTRONIC PUERTO RICO; ceiba norte industrial park, r; juncos PR 00777
• Manufacturer (Section G): MEDTRONIC MED REL MEDTRONIC PUERTO RICO; ceiba norte industrial park, r; juncos PR 00777
• Manufacturer Contact: diane wolf ; 7000 central avenue ne rcw215; minneapolis, MN 55432 ; 7635263987
• MDR Report Key: 5741161
• MDR Text Key: 47908369
• Report Number: 3004209178-2016-12674
• 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: Other
• Type of Report: Initial,Followup
• Report Date: 06/22/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/22/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 08/28/2013
• Device Model Number: 37714
• Device Catalogue Number: 37714
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 05/25/2016
• Date Device Manufactured: 10/08/2012
• 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: 41 YR