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

Model Number 97714

Device Problems Energy Output To Patient Tissue Incorrect (1209); Delayed Charge Time (2586); Charging Problem (2892); Communication or Transmission Problem (2896)

Patient Problems Pain (1994); Numbness (2415)

Event Type  malfunction  

Event Description

Information was received from a consumer regarding a patient who was implanted with an implantable neurostimulator (ins) for non-malignant pain and post lumbar laminectomy syndrome.It was reported that the patient had poor coupling.They were having trouble with trying to get their charger on because they can sit during the recharging session and hold the antenna on their back to get it right on the spot but it would go off.When asked to clarify what they meant by "goes off" they responded that their recharger would all of a sudden beep like it didn't have good connection.They think there was something wrong with the recharger.The patient said they would see full coupling boxes on their recharger when they charged the ins and the patient would be sitting still, and for some odd reason the recharger would lose connection and beep like it needed to be fixed, but the patient hadn't moved during the charging.It was driving them crazy to get the ins charged up- sometimes they couldn't sit when they charged and they had to stand up; this hurt the patient's back.The patient didn't want to turn the ins stimulation up because they would feel it in their leg and they didn't like that.The patient thought it was specifically an issue with their losing coupling boxes; they lost all coupling boxes, when they started from full, about two seconds after starting a charge session.It took the patient six hours straight to charge their ins, which wasn't normal, because they had to elevate their bed halfway to get the ins to charge.The patient was sent adhesive discs to help with the coupling issue.The patient reported having other issues because they didn't know if their wires had moved from their spine but they were having numbness in their left knee.The already saw their healthcare provider and they performed an mri but their healthcare provider told the patient that it had to do with other issues in their back.No further complications 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: 7053663
• MDR Text Key: 93085428
• Report Number: 3004209178-2017-24263
• Device Sequence Number: 1
• Product Code: LGW
• UDI-Device Identifier: 00643169109483
• UDI-Public: 00643169109483
• 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: Other
• Type of Report: Initial
• Report Date: 11/22/2017

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: 12/28/2017
• Device Model Number: 97714
• Device Catalogue Number: 97714
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 11/21/2017
• Initial Date FDA Received: 11/22/2017
• Date Device Manufactured: 02/06/2017
• 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