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

Model Number 97702

Device Problems Failure to Deliver Energy (1211); Labelling, Instructions for Use or Training Problem (1318); Communication or Transmission Problem (2896)

Patient Problems Pain (1994); Therapeutic Effects, Unexpected (2099); Ambulation Difficulties (2544)

Event Date 12/11/2018

Event Type  malfunction  

Manufacturer Narrative

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

Event Description

Information was received from a patient regarding their implantable neurostimulator (ins) that was implanted for non-malignant pain.It was reported that patient thinks the ins needs to be reprogrammed.Caller states she is in so much pain and cannot hardly walk.She placed the patient programmer (pp) on the ins it does not register so she can increase it.Caller is seeing the poor communication screen.Caller then resolved this by placing the pp on the skin.Caller states she does not understand how to read the book to reset the ins, but she could not find the book.After the caller synced the pp to the ins she was seeing stim off and group a 0.0v.Caller states she did not know the ins was off and set to 0.0v.Patient was walked through turning the ins back on and increasing the stimulation up to 3.60v.Caller states she can feel the stimulation and it is comfortable.Troubleshooting resolved reported issue.No further complications were reported/anticipated.

Manufacturer Narrative

Concomitant medical products: product id: neu_label_acc, serial# unknown, product type: accessory.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: 8159502
• MDR Text Key: 130359953
• Report Number: 3004209178-2018-27534
• Device Sequence Number: 1
• Product Code: LGW
• UDI-Device Identifier: 00643169109513
• UDI-Public: 00643169109513
• 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: 12/19/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/13/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 08/14/2017
• Device Model Number: 97702
• Device Catalogue Number: 97702
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 12/11/2018
• Date Device Manufactured: 02/22/2016
• 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: 79 YR