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

Model Number 97714

Device Problems Migration or Expulsion of Device (1395); Overheating of Device (1437); Therapy Delivered to Incorrect Body Area (1508); Device Operates Differently Than Expected (2913)

Patient Problems Burn(s) (1757); Undesired Nerve Stimulation (1980); Pain (1994); Therapeutic Effects, Unexpected (2099); Burning Sensation (2146); Therapeutic Response, Decreased (2271); Complaint, Ill-Defined (2331); Injury (2348)

Event Date 01/17/2017

Event Type  malfunction  

Manufacturer Narrative

Section d information references the main component of the system and other applicable components are: product id 97754 lot# serial# (b)(4) implanted: explanted: product type recharger.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

The manufacturer representative (rep) reported burning at the battery site.Whenever the patient places their recharger over their battery directly on their skin, they had a burning sensation.It was reported that it was not hot temperature wise but burns.The patient was currently on work disability and they were trying to clear them to return to the workforce but with this issue, there was "no way" they could.When the rep used their programmer and as soon as the programmer was put over the battery site, the patient jumped with burning.It was the same type of telemetry head as the patient's programmer.After they put their programmer back on the battery site, the patient never complained of the burning again.Impedances were checked which were all within normal limits and they reprogrammed the patient, giving them four different programming options to choose from as well as activating their sensor.The patient was very happy with the result.The issue was not resolved at the time of the report.When the patient first had burning, there was a concern about a possible infection.The healthcare professional assessed the wounds which looked perfect where there were no redness, swelling, or tissue that was hot to touch.No surgical intervention occurred and no surgical intervention was planned.Relevant medical history includes complex regional pain syndrome type i and spinal pain.

Manufacturer Narrative

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

Additional information was received from the manufacturer representative.It was reported that the patient was continuing to experience burning from the beginning of a charging session.The patient was now reporting decreased relief with stimulation as well, despite having good coverage.The manufacturer added hd options to address the issue and educated the patient about turning off adaptive stimulation (as) as the patient indicated positional changes were part of the issue.No further complications were reported or anticipated.

Manufacturer Narrative

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

Manufacturer Narrative

Other applicable components are product id 97754 (b)(4) product type recharger product id 977c165 (b)(4) implanted: (b)(6) product type lead conclusion codeapplies to the ins and conclusion code applies to the lead.If information is provided in the future, a supplemental report will be issued.

Event Description

Additional information was received from the manufacturer representative.It was reported that the patient¿s current program wasn¿t helping.The manufacturer representative stated that it was helping the patient, but now they were experiencing stimulation in the area of their ovary/bladder.Because of that, the patient believed that their lead had moved.It was reported that the patient was also expecting pain while going to the bathroom.The manufacturer representative stated that there was an hd group that helped when the patient was resting, but when they were up and active the pain would return.It was noted that a reprogramming session was scheduled.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: 6264683
• MDR Text Key: 65306584
• Report Number: 3004209178-2017-01284
• 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: company representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup,Followup
• Report Date: 09/05/2017

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: 97714
• Device Catalogue Number: 97714
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 01/17/2017
• Initial Date FDA Received: 01/19/2017
• Supplement Dates Manufacturer Received: 06/26/2017; 08/16/2017; 08/16/2017
• Supplement Dates FDA Received: 07/12/2017; 09/05/2017; 09/06/2017
• Date Device Manufactured: 09/30/2016
• 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: 44 YR