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

Model Number 97714

Device Problem Overheating of Device (1437)

Patient Problems Burn(s) (1757); Skin Inflammation (2443)

Event Type  malfunction  

Manufacturer Narrative

The main component of the system and other applicable components are: product id: 37791, serial# unknown, product type: recharger.Product id: 97754, serial# (b)(4), product type: recharger.

Event Description

The consumer reported via the manufacturer representative that they had heating during charging.The device was reprogrammed and recharging was reviewed.The representative reported that the recharging antenna was getting hot while charging.The antenna was damaged.A replacement was sent.This indication for use was non-malignant pain.The consumer reported that the recharger burnt them and caused blistering of the skin on their chest.There was a report that the patient was told that the temperature sensor inside the recharger antenna and that must have failed.It was reported that the recharger burnt the patient.They were given a replacement recharger.

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 consumer indicating that they require a manufacturer representative to inquire about a reimbursement.The caller reinstates that their implantable neurostimulator recharger (insr) antenna is too hot and burning him and that the patient programmer (pp) was junk.The caller is wondering why a follow-up letter is being sent after their device was explanted.The caller requested a status update on their analysis report and was informed the analysis report will be sent to their healthcare professional.

Manufacturer Narrative

Analysis of the implantable neurostimulator (nmd721194h) found that there were no anomalies.

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 patient.It was reported that the patient had not heard back regarding the analysis of the device.The patient stated they would prefer to work it out with the manufacturer and not have to get a lawyer.The patient stated the charger messed up, referring to the issues already reported.The patient wanted to be reimbursed.A request to patient relations was sent.It was reported the analysis letter was mailed out on march 30, 2017 to the patient¿s doctor.A message was left with the patient.No further complications were reported/expected.

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: 6168248
• MDR Text Key: 62374451
• Report Number: 3004209178-2016-26292
• Device Sequence Number: 1
• Product Code: LGW
• UDI-Device Identifier: 00643169109483
• UDI-Public: 00643169109483
• Combination Product (y/n): N
• PMA/PMN Number: P840001
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,consum
• Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup,Followup,Followup
• Report Date: 05/01/2017

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: 01/14/2016
• Device Model Number: 97714
• Device Catalogue Number: 97714
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/09/2017
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 12/09/2016
• Initial Date FDA Received: 12/12/2016
• Supplement Dates Manufacturer Received: Not provided; Not provided; Not provided; 04/03/2017
• Supplement Dates FDA Received: 02/03/2017; 03/27/2017; 05/01/2017; 09/28/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 02/26/2015
• 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