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

Model Number 97714

Device Problems Delayed Charge Time (2586); Charging Problem (2892); Device Operates Differently Than Expected (2913)

Patient Problems Rash (2033); Therapeutic Effects, Unexpected (2099); Tingling (2171); Reaction (2414); Test Result (2695)

Event Date 04/11/2017

Event Type  Injury  

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

Information was received from a manufacturer's representative (rep) regarding an implantable neurostimulator (ins) for the treatment of spinal pain.It was reported that the patient has a rash all over their body.No allergies were confirmed.The rep stated that the patient was sent to a dermatologist.The patient doesn't have seasonal allergies and is not on antibiotics that could have contributed to the rash.The patient saw a dermatologist.The rep stated that the dermatologist thinks that it looks like a metal reactions.The patient was given a steroid and may be sent for allergy testing.No device allegations were reported.Additional information was received from the rep stating that the physician referred the patient to a dermatologist and the patient was prescribed meds for the rash.The rep provided a sheet that includes all metals to physicians for their review.No allergy test was performed at this time.The rep spoke to the patient and his rash had improved but still has some residual lesions.Dermatologist was not sure of the cause however suspected nickel or gold could have caused such a rash.If rash continues they plan to refer the patient to (b)(6) for an allergy test.Additional information was received from the patient via manufacturer representative.It was reported that the a blood test was performed indicating that the patient had high levels of chromium and nickel in their blood, which might have been responsible for the rash and discomfort.The patient stated that the medicine they were provided with had reduced the severity of the rash, but that the rash would continue each time they recharged their implant battery using the system.The patient mentioned that they wanted to reach a solution that would help their stimulator be both effective and problem-free.No further complications were reported or anticipated.Additional information was received from the consumer reporting the metal-llt analysis report indicated: bone cement particles mildly reactive, chromium reactive, nickel reactive, vanadium mildly reactive, zirconium mildly reactive.The consumer further reported via a rep that the patient gets reaction a when charging, that was somewhat systemic in that it was in the patient's back, arms and sometime their face.The patient relies on system for pain control using high dose settings but hasn't gotten the best pain relief, thought the system was providing more than 50% relief.The patient has complained of taking a long time t o charge (everyday - sometimes for 2-3 hours) and their wife does most of the charging since the patient has limited range of motion.Low dose programming was tried on the patient but the patient couldn't stand the tingling sensation, therefore, needs high dose programming.The patient was charging daily as they were using hd settings.The rep will be attending an appointment the patient has in two days with their doctor.No further complications were reported.

Manufacturer Narrative

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

Event Description

Additional information was received from the rep.The patient did not mention to the rep the charging time issue, therefore no intervention/actions were taken.The rep stated that the stimulator was reprogrammed as an action/intervention to help ins be both effective and problem free.The cause of the rash is unknown.The rash is being treated by oral medications.

• 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: 6728797
• MDR Text Key: 80574814
• Report Number: 3004209178-2017-15220
• 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,consum
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 08/23/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/20/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 11/28/2017
• Device Model Number: 97714
• Device Catalogue Number: 97714
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 08/21/2017
• Date Device Manufactured: 12/28/2016
• 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 Outcome(s): Required Intervention
• Patient Age: 77 YR