MAUDE Adverse Event Report: MEDTRONIC PUERTO RICO OPERATIONS CO. SURESCAN STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF

Model Number 97714

Device Problems Use of Device Problem (1670); Device Displays Incorrect Message (2591); Charging Problem (2892); Communication or Transmission Problem (2896)

Patient Problems Unspecified Infection (1930); Distress (2329); Discomfort (2330); Malaise (2359); Impaired Healing (2378)

Event Date 09/30/2016

Event Type  Injury  

Manufacturer Narrative

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

Event Description

The patient reported that they were getting poor coupling when recharging. Recharging best practices were reviewed at the time of the report, and the patient then noted getting 6-8 coupling bars. The patient mentioned that they were recently implanted on (b)(6) 2016-09-15, and got an infection at their implant site. The patient stated that they noticed the infection at the end of september, and was given ¿some giant pills¿ that make them sick. Due to the patient¿s infection, they have been in 2 different hospitals. At the time of the report, it was noted that the patient was confused on recharging. They stated they are frustrated and upset because they can¿t get any bars to show up. The patient mentioned they are uncomfortable and need to lie down. It was reported that a manufacturing representative would meet with the patient to show them on how to use recharging equipment. The patient stated they cannot find the correct place for the recharger, and it is driving them crazy. They noted they have been trying to charge since the sunday prior to the report, and is now low on charge. It was reported that the patient¿s recharger does not show that the ins is on; it¿s blank. The patient mentioned that they are charging over their underpants, because they have not healed very much since implant. The patient was implanted for non-malignant pain.

• Brand Name: SURESCAN
• Type of Device: STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF
• 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: diane wolf ; 7000 central avenue ne rcw215; minneapolis, MN 55432 ; 7635263987
• MDR Report Key: 6074087
• MDR Text Key: 101192695
• Report Number: 3004209178-2016-23084
• 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

• Type of Report: Initial,Followup
• Report Date: 11/02/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/02/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes

Device Operator

• Device Expiration Date: 11/28/2016
• Device Model Number: 97714
• Device Catalogue Number: 97714
• 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: 10/10/2016
• Was Device Evaluated by Manufacturer?: No Answer Provided
• Date Device Manufactured: 01/09/2016
• 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: 11/02/2016 Patient Sequence Number: 1