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

Model Number 97702

Device Problem Migration or Expulsion of Device (1395)

Patient Problems Pain (1994); Complaint, Ill-Defined (2331); Loss of consciousness (2418); Sleep Dysfunction (2517)

Event Date 04/29/2019

Event Type  Injury  

Manufacturer Narrative

Other relevant device(s) are: product id: 977a260, serial#: (b)(4), implanted: (b)(6) 2017, product type: lead.Product id: 977a260, serial#: (b)(4), implanted: (b)(6) 2017,product type: lead.If information is provided in the future, a supplemental report will be issued.

Event Description

Information was received from a manufacturer representative (rep) regarding a patient who was implanted with a neurostimulator for spinal pain.It was reported that the patient had a recent thoracic x-ray done due to an increase in pain to their right leg.It was noted that the implantable neurostimulator (ins) was placed for left leg pain in 2017.After reviewing the x-rays, it appeared that one lead (0-7) had migrated to the ins.The patient denied any falls or trauma.The rep interrogated the ins, impedances were within normal limits.Both leads were programmed, the 0-7 lead provided stimulation over the ins, and the 8-15 lead provided bilateral equal stimulation according to the patient.In the end, extensive reprogramming was one with the patient and the patient was able to report good coverage.There were no further complications reported or anticipated.

Manufacturer Narrative

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

Event Description

Additional information was received.No new information.

Manufacturer Narrative

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

Event Description

Additional information was received from the patient.The patient reported that one of their leads fell to the bottom of their back and it is causing pain and they can't sleep.They stated that when the ¿wire¿ fell down and it ¿through them into something¿ and they ¿blacked out.¿ they mentioned that if they cough or sneeze, they feel like their whole insides are coming out.The patient stated that they saw their healthcare provider (hcp) and was told they would have to wait a month before anything would be done about the issue.The patient mentioned that they wanted to have the device removed because it never worked.The patient was sent physician listings and was to follow-up with their healthcare provider.

• 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: 8567654
• MDR Text Key: 143995047
• Report Number: 3004209178-2019-08629
• 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: company representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date: 02/06/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/30/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 12/14/2017
• Device Model Number: 97702
• Device Catalogue Number: 97702
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 01/22/2020
• Date Device Manufactured: 06/17/2016
• 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): Other
• Patient Age: 81 YR