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

Model Number 97712

Device Problems Energy Output To Patient Tissue Incorrect (1209); Unexpected Therapeutic Results (1631); Device Operates Differently Than Expected (2913)

Patient Problems Pain (1994); Therapeutic Effects, Unexpected (2099); Therapeutic Response, Decreased (2271); Sleep Dysfunction (2517)

Event Date 09/01/2017

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 consumer regarding an implantable neurostimulator (ins) for the treatment of spinal pain.It was reported that the patient had a trial for 3-4 days and it worked.The caller stated that the new device is not working, and is not relieving pain at all.The caller stated that it was helping in the beginning and now it is not helping at all.The caller stated that when the patient turns stimulation off they can feel it in their feet and legs and it goes on for several hours or a day or two, which disrupts the patient's sleep.The caller also stated that they are having more migraine headaches.The patient stated that they tried their program b, which is high density, and the program has the same issues.No further complications were reported or anticipated.

• 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: 6987919
• MDR Text Key: 91082101
• Report Number: 3004209178-2017-22780
• Device Sequence Number: 1
• Product Code: LGW
• UDI-Device Identifier: 00643169109506
• UDI-Public: 00643169109506
• Combination Product (y/n): N
• PMA/PMN Number: P840001
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 10/30/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 08/28/2017
• Device Model Number: 97712
• Device Catalogue Number: 97712
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 10/26/2017
• Initial Date FDA Received: 10/30/2017
• Date Device Manufactured: 10/03/2016
• 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: 71 YR