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

Model Number 97714

Device Problems Overheating of Device (1437); Inappropriate/Inadequate Shock/Stimulation (1574); Improper or Incorrect Procedure or Method (2017); Low Battery (2584); Charging Problem (2892); Device Operates Differently Than Expected (2913)

Patient Problems Burning Sensation (2146); Electric Shock (2554)

Event Date 11/01/2016

Event Type  Injury  

Manufacturer Narrative

Concomitant medical products: product id: 977a260, lot#: va0gbnf037, implanted: (b)(6) 2014, product type: lead.Product id: 977a260, lot#: va0gbnf038, implanted: (b)(6) 2014, product type: lead.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

A consumer reported that on (b)(6) 2016 they bent over and felt a sudden burning sensation at the implantable neurostimulator (ins) site.They felt like something happened to the lead.On (b)(6) 2016 they felt the same sensation under their armpit on the left side near their shoulder blade or spine.The patient was going to follow-up with their doctor.The patient was implanted for non-malignant 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 a health care provider stating that the patient is no longer being seen at mcw as doctor (b)(6) is no longer working there.

Manufacturer Narrative

References the main component of the system and other applicable components are: product id 977a260, lot# va0gbnf037, implanted: (b)(6) 2014, product type: lead.Product id: 977a260, lot# va0gbnf038, implanted: (b)(6) 2014, product type lead.

Event Description

Additional information was received from the patient via a manufacturer¿s representative (rep).The rep reported that the patient reported back in (b)(6) out of nowhere stimulation got very intense while reaching for something to the point where it was ¿shocking¿ her.The rep reported that the patient turned stimulation off and never turned back on after that, was afraid to use.The rep reported that the patient experienced deep burning since then at the battery site and neck where the leads were implanted.The rep reported that the patient had experienced this every day since.The rep reported that the patient had not charged her battery since an unknown day in (b)(6).The rep reported that the patient denied any environmental/external/patient factors that could have led or contributed to the issue.The rep reported that the battery was overdischarged.The rep reported that a physician recharge was performed and the patient was able to charge after.The rep reported that the patient charged to 50% and the rep was able to read out the battery and perform an impedance check.The rep reported that all impedances were within the 600 range.The rep reported that they turned stimulation on at that point and the patient got appropriate coverage without shocking or burning.The rep reported that they were seeing the patient again on (b)(6) 2017.No further complications anticipated.

Event Description

Additional information received from the manufacturer representative reported that the patient stated the implant didn¿t want to charge and she had to charge frequently to keep it running.It was unknown if any diagnostic evaluations were done to determine if there was an issue or if the frequent charging was due to settings.It was noted that charging was burdensome and the doctor elected to go ahead and replace the implant with a primary cell device.

Manufacturer Narrative

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

• 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: 6274355
• MDR Text Key: 65641022
• Report Number: 3004209178-2017-01615
• 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,health professional
• Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup,Followup,Followup
• Report Date: 05/05/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/24/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 12/28/2014
• Device Model Number: 97714
• Device Catalogue Number: 97714
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 05/01/2017
• Date Device Manufactured: 01/29/2014
• 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 Outcome(s): Required Intervention
• Patient Age: 57 YR