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

Model Number 97714

Device Problems Unstable (1667); Charging Problem (2892); Communication or Transmission Problem (2896)

Patient Problems Therapeutic Effects, Unexpected (2099); No Known Impact Or Consequence To Patient (2692)

Event Date 01/27/2017

Event Type  Injury  

Event Description

Information was received via a manufacturer representative from a healthcare professional regarding a patient with an implantable neurostimulator (ins).The patient was able to charge the ins from (b)(6) to the first week of (b)(6).However, it was also reported the patient had never been able to charge properly since implant.The patient has not able to charge; there was no coupling.Another recharger was tried, and the same issue occurred.The area around the ins did not seem swollen and the ins can be interrogated with the clinician programmer and patient programmer.It was indicated that the ins was implanted in the left buttock.An x-ray was performed in (b)(6) with an anterior-posterior view.The consultant thought it looked the right way around, however, there may have been some confusion.Based on the anterior-posterior x-ray of the ins implanted in the left buttock, it was believed by the technical specialist that the ins was flipped as the leads were not pointing towards the spine in the x-ray.No patient symptoms were reported.

Event Description

Additional information from the manufacturer representative verified the recharging issues occurred apparently from the outset.The patient experienced a lack of therapy and inability to charge.The patient was brought back for a surgical intervention and the battery was found to be flipped.All was checked now and the equipment was working.No further patient complication was reported as a result of the event.

• Brand Name: SURESCAN
• Type of Device: STIMULATOR, SPINAL-CORD, IMPLANTED (PAIN RELIEF)
• Manufacturer (Section D): MEDTRONIC PUERTO RICO OPERATIONS CO.; road 31, km. 24, hm 4; ceiba norte industrial park; juncos,pr MN 00777 1200
• Manufacturer (Section G): MEDTRONIC PUERTO RICO OPERATIONS CO.; road 31, km. 24, hm 4; ceiba norte industrial park; juncos,pr MN 00777 1200
• Manufacturer Contact: lisa woodward clark ; 7000 central avenue ne rcw215; minneapolis, MN 55432 ; 7635263920
• MDR Report Key: 6418300
• MDR Text Key: 70434441
• Report Number: 3007566237-2017-01042
• Device Sequence Number: 1
• Product Code: GZB
• Combination Product (y/n): N
• Reporter Country Code: UK
• PMA/PMN Number: P840001
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 04/27/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/20/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 10/28/2017
• Device Model Number: 97714
• Device Catalogue Number: 97714
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 04/26/2017
• Date Device Manufactured: 12/12/2016
• 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