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

Model Number 97712

Device Problems Overheating of Device (1437); Therapy Delivered to Incorrect Body Area (1508); Device Displays Incorrect Message (2591); Charging Problem (2892); Device Operates Differently Than Expected (2913); Material Deformation (2976)

Patient Problems Undesired Nerve Stimulation (1980); Pain (1994); Seroma (2069); Burning Sensation (2146); Discomfort (2330); Complaint, Ill-Defined (2331)

Event Type  malfunction  

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 consumer through a manufacturer representative (rep) regarding a patient implanted with a neurostimulator (ins) for spinal pain.It was reported by the patient that they were experiencing a feeling of heat or warmth in the pocket when the therapy was on.It is unknown if this occured when the patient was recharging, or just when stim was on.The rep also did not know if the patient was getting good therapy.No further patient complications have been reported as a result of this event.

Manufacturer Narrative

Concomitant medical products: product id neu_unknown_ext, product type: extension.

Event Description

Additional information received from the manufacturer¿s representative (rep) reported they were with the patient and were seeing the ¿neurostimulator batteries were depleted, replace batteries now¿ message.According to the rep.They had seen a similar message previously.It was further reported the patient had been unable to charge because the site hurt to the touch which occurred with stimulation off but was more pronounced when stimulation was on or while recharging.The issue also occurred when there was pressure on the site, if the patient moved in a certain way, or when lying on the site which had been occurring since implant but had progressively gotten more uncomfortable.It was confirmed the patient was getting coverage and the system appeared to be fully functional when it was on except for some abdominal/rib stimulation which had been occurring since implant.The rep.Palpated the system and it wasn¿t red, warm, puffy, or swollen but it did have fluid and a ¿spongy¿ feel.The rep.Asked the consumer if it felt like a shock/jolting to which they replied yes, but then said it felt ¿more like when you have a cut and it burned¿ and they could feel that all the way around the ins.It was noted the consumer had a history of seroma and had one immediately following implant.An mri was performed which showed the system looked intact but there was a lot of coiling of the extension behind the ins.The rep.Was going to discuss possible pocket/lead revision with the physician and go from there.No further complications were reported.

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: 6417317
• MDR Text Key: 70341818
• Report Number: 3004209178-2017-05915
• Device Sequence Number: 1
• Product Code: GZB
• UDI-Device Identifier: 00643169109506
• UDI-Public: 00643169109506
• 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,Followup
• Report Date: 03/28/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/20/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 03/28/2017
• Device Model Number: 97712
• Device Catalogue Number: 97712
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 03/21/2017
• Date Device Manufactured: 05/11/2016
• 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