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

Model Number 97714

Device Problems Delayed Charge Time (2586); Charging Problem (2892)

Patient Problems Pain (1994); Therapeutic Effects, Unexpected (2099); Therapeutic Response, Decreased (2271); Discomfort (2330); Ambulation Difficulties (2544)

Event Date 10/01/2016

Event Type  malfunction  

Manufacturer Narrative

Concomitant medical products: product id 977a260, serial# (b)(4), implanted: (b)(6) 2016, product type: lead.Product id 37701, serial# (b)(4), implanted: (b)(6) 2011, product type: implantable neurostimulator.Product id 3778-60, serial# (b)(4), implanted: (b)(6) 2011, product type: lead.Note: patient has two systems - each system has one ins and one lead.It is currently unknown which ins and lead(s) may be contributing to the reported event.(b)(4).A good faith effort will be made to obtain the applicable information relevant to the report.If information is provided in the future, a supplemental report will be issued.

Event Description

Information was received from a consumer regarding a patient who was implanted with an implantable neurostimulator (ins) for spinal pain.It was reported that in late (b)(6) 2017, the patient started noticing charging was taking forever; they have been needing to charge every single day for a good three hours.The patient had also started experiencing the same pain they were implanted for, even when their ins was off.The patient originally had a constant pain in their left leg, and started noticing it in (b)(6) 2016, and then the pain moved into their right leg as well in (b)(6) 2017.It was also noted the patient was more comfortable with the ins off than when it was on.The patient was getting good coupling when recharging.It was noted that they had met with a manufacturer representative who added a "d-mode" in their programmer, and if they turned the stimulation up real high they could get rid of the pain but it drained their ins more.They were redirected to their doctor to diagnose the increased recharging needs, assess the pain and to perform reprogramming to see if they can get stimulation more on one side in one leg.The patient was scheduled for a mri of their lumbar spine and a cat scan with intravenous contrast myelogram to check the their leads to see if the leads have pulled away from their spine and may be contributing to the pain.It was also noted the mri was also being done to see if it can be determined why the time to recharge has increased.No further complications were reported or anticipated.

Manufacturer Narrative

The main component of the system and other applicable components are: product id: 977a260, serial# (b)(4), implanted: (b)(6) 2016, product type: lead.Product id: 3778-60, serial# (b)(4), implanted: (b)(6) 2011, product type: lead.

Event Description

Additional information was received from the patient.The patient reported that they did not know the circumstances that led to the pain and the longer recharging times.The patient reported that they did not know that they could contact their manufacturer representative about the pain.The patient clarified that they only had one device implanted currently and that their previous device was a primary cell ins that had been explanted on (b)(6) 2016.The patient was unaware of any circumstances that led to the leg pain and mentioned that they had the stimulation so high to get rid of the pain that they had to charge the device every day for 3 hours.The patient reported that the pain was so bad that they have not been able to walk for at least a month.The patient reported that the pain/recharging issues had not yet been resolved.No further complications are anticipated.

Manufacturer Narrative

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

• Brand Name: SURESCAN
• Type of Device: STIMULATOR, SPINAL-CORD, IMPLANTED (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 clark ; 7000 central avenue ne rcw215; minneapolis, MN 55432 ; 7635263920
• MDR Report Key: 6415424
• MDR Text Key: 70343392
• Report Number: 3004209178-2017-05886
• Device Sequence Number: 1
• Product Code: GZB
• 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,Followup,Followup
• Report Date: 04/06/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/17/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 10/28/2016
• Device Model Number: 97714
• Device Catalogue Number: 97714
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 03/23/2017
• Date Device Manufactured: 12/08/2015
• 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: 55 YR