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

Model Number 97712

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Itching Sensation (1943); Pain (1994); Skin Irritation (2076); Reaction (2414)

Event Date 01/28/2016

Event Type  Injury  

Manufacturer Narrative

Information references the main component of the system and other applicable components are: product id: 97791, product type: accessory.Product id: 977a275, serial# (b)(4), implanted: (b)(6) 2016, product type: lead.Product id: 977a275, serial# (b)(4), implanted: (b)(6) 2016, product type: lead.Product id: 97791, product type: accessory.Analysis results were not available at the time of this report.A follow-up report will be sent when analysis is completed.

Event Description

A consumer implanted for complex regional pain syndrome type i and spinal pain reported via the manufacturer's representative (rep) that since therapy was turned on a week after implant, they experienced itching from head to toe after stimulation had been on for a while.When the consumer turned therapy off the sensation went away.The rep.Tried changing the rate, but it didn't resolve the issue.Additional information received from the manufacturer's representative (rep) reported no further diagnostic tests had been performed and they didn't think the cause had been determined.The rep.Wasn't sure if any interventions had taken place, but the consumer was supposed to see the physician the week of may 16th.The device was later explanted and returned for analysis.

Manufacturer Narrative

Analysis of the implantable neurostimulator (s/n (b)(4)) found no anomaly.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.

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 received from the manufacturer's representative (rep) reported that prior to explant the consumer experienced pain and itching at the implantable neurostimulator (ins) site when stimulation was turned on.As a result they had been unable to use it due to reports of increased itching and sensitivity at the site whenever it was turned on.These issues resulted in an unscheduled clinic visit where the consumer was diagnosed with pruritus and was instructed to continue applying lidocaine 5% topical appointment three times every day to the implantable neurostimulator (ins) site for sensitivity and pain.The event resolved without sequelae on (b)(6) 2016 after the device removed.

Event Description

Additional information was received from the patient that reported that whenever the patient had her stimulation turned on, she had experienced severe itching.She had a really bad reaction only when the stimulation was on.When the stimulation was turned off she was fine.The patient had a full system explant and now the itching has resolved.It was noted that the patient had a knee replacement.

Manufacturer Narrative

(device evaluated): product event summary #the ins was returned and analysis found no anomaly.Evaluation determined that there was no allegation of a device failure, but standard investigation is needed because the event was determined to be reportable to a regulatory body.The source information indicates a potential relationship between the adverse event(s) reported and the device therapy.Assessment determined that there is not an existing formal investigation for the issue identified in this event.However, a formal investigation is not needed because the issue identified in this event is a known inherent risk as disclosed in product labeling, and additional investigation is not needed.Supporting event information used to determine the issue was a known event includes that the patient had the system explanted due to pain at the implantable neurostimulator pocket; however the root cause of why the patient experienced itching and sensitivity with the implant on remains unknown since the device was explanted and analysis found no indication of an anomaly.

Event Description

Device evaluated.

Manufacturer Narrative

Corrected information: sex, date of birth.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: diane wolf ; 7000 central avenue ne rcw215; minneapolis, MN 55432 ; 7635263987
• MDR Report Key: 5731970
• MDR Text Key: 47594317
• Report Number: 3004209178-2016-12418
• Device Sequence Number: 1
• Product Code: GZB
• 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,Followup,Followup
• Report Date: 12/13/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/17/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 04/14/2016
• Device Model Number: 97712
• Device Catalogue Number: 97712
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/16/2016
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 11/14/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 05/26/2015
• 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
• Patient Outcome(s): Required Intervention
• Patient Age: 54 YR