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); Energy Output Problem (1431); Inappropriate/Inadequate Shock/Stimulation (1574); Data Problem (3196)

Patient Problems Pain (1994); Cramp(s) (2193); Electric Shock (2554)

Event Date 11/20/2019

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 via manufacturer representative, regarding patient's implantable neurostimulator (ins).Patient said stimulator was causing shocking down the leg and that she couldn't make it turn off.She also claimed it was changing programs on its own.The cause was not known.Rep did an impedance and battery check.Rep read the device with the clinician programmer and it was off already.Patient said it was still going so then the rep showed her with her patient programmer that it is off and has been off.Patient still said it was shocking/leg cramp pain.Her son was also present and said maybe it¿s a leg pain problem.Rep agreed.Rep told the patient she needed to go to the er if it¿s that bad.Patient said it¿s not that bad.Once the rep explained it wasn't the stimulator since it was off, patient started to feel better.The issue was resolved.Rep got a text 20 min after they left her and she said she was doing much better.Rep explained they didn't do anything but rep thought patient's mind just needed to know from the rep it wasn't the stimulator.Hcp had no further information.Patient's weight was asked but unknown.No further complications were reported.

• 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: 9370547
• MDR Text Key: 178248671
• Report Number: 3004209178-2019-22543
• 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,consum
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 11/25/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/25/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 05/14/2019
• Device Model Number: 97702
• Device Catalogue Number: 97702
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 11/20/2019
• Date Device Manufactured: 11/21/2017
• 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: 54 YR