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

Model Number 97712

Device Problems Display or Visual Feedback Problem (1184); Mechanical Problem (1384); Malposition of Device (2616); Charging Problem (2892); Communication or Transmission Problem (2896); Insufficient Information (3190)

Patient Problem Complaint, Ill-Defined (2331)

Event Date 03/04/2020

Event Type  malfunction  

Manufacturer Narrative

Concomitant medical products: product id: 97754, serial# (b)(4), product type: recharger.If information is provided in the future, a supplemental report will be issued.

Event Description

Information was received from a consumer regarding a patient's implantable neurostimulator (ins).It was reported that the ins is located "in the worst place they could have put it".They said due to the ins location, they have struggled to connect to their ins and it was making their symptoms worse.They said due to this, they didn't charge their ins.The patient said they used their ins and charged for a while, but stated that it "became a chore".They said this started since date of implant.They also reported they haven't charged their ins in over a year and stated they were getting the reposition antenna screen on the insr (implantable neurostimulator recharger).They said there were no coupling boxes on the insr and the battery at the top is fully charged.They said the ins battery was flashing, but no efficiency bars were on the insr.The patient pressed the x on the insr and it didn¿t do anything.The patient confirmed insr was responding when they pressed the audio button.They said the reposition antenna screen would change on its own to the main insr screen.They stated they first noticed this issue this past week in march.No further complications reported/anticipated.

Manufacturer Narrative

Product id 97754, serial# (b)(4).Product type recharger.Review of this mdr and/or additional information received shows that there is no evidence to reasonably suggest that the device in this report may has malfunctioned and that the device or a similar device would be likely to cause or contribute to a death or serious injury if the malfunction were to recur.Therefore, this event did not and does not meet the reporting requirements stipulated in 21 cfr 803.If information is provided in the future, a supplemental report will be issued.

• 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: lisa woodward clark ; 7000 central avenue ne rcw215; minneapolis, MN 55432 ; 7635263920
• MDR Report Key: 9924207
• MDR Text Key: 186407720
• Report Number: 3004209178-2020-06696
• Device Sequence Number: 1
• Product Code: LGW
• UDI-Device Identifier: 00643169109506
• UDI-Public: 00643169109506
• 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,Followup
• Report Date: 04/14/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/03/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 04/14/2017
• Device Model Number: 97712
• Device Catalogue Number: 97712
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 04/06/2020
• Date Device Manufactured: 05/16/2016
• 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 Age: 55 YR