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

Model Number 97702

Device Problem Overheating of Device (1437)

Patient Problems Erythema (1840); Inflammation (1932); Pain (1994); Burning Sensation (2146); Skin Inflammation (2443)

Event Date 01/02/2017

Event Type  Injury  

Manufacturer Narrative

Concomitant products: product id: 977a275, serial# (b)(4), implanted: (b)(6) 2016, product type: lead.

Event Description

The healthcare professional (hcp) of a clinical study reported that there were issues regarding the implantable neurostimulator (ins) pocket.It was 15 days after the last surgery ((b)(6) 2016) the patient presented with inflammation symptoms around the ins pocket redness, blisters, pain, and heat.There was no environmental/external/patient factors that may have led or contributed to the issue except the implantable neurostimulator (ins) which was just below the skin (2.7 mm).Blood analysis showed no infection.Echography showed no forgotten compress.Interventions included a revision of the implantable neurostimulator (ins) pocket to explore the site including tissue sampling and ins repositioning.The issue was not resolved at the time of report.

Manufacturer Narrative

Analysis results were not available as of the date of this report.A follow-up report will be submitted when analysis is complete.If information is provided in the future, a supplemental report will be issued.

Manufacturer Narrative

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

Manufacturer Narrative

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

Event Description

Additional information from the healthcare professional via the manufacturer representative reported the ins was explanted on (b)(6) 2017.The ins was explanted because the pocket of the ins seemed to be inflamed (burning sensations, redness¿).No infection was established.The patient was re-implanted on (b)(6) 2017.

Manufacturer Narrative

Analysis found the ins was functionally okay.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: 6414773
• MDR Text Key: 70258778
• Report Number: 3004209178-2017-05865
• Device Sequence Number: 1
• Product Code: LGW
• Combination Product (y/n): N
• Reporter Country Code: FR
• PMA/PMN Number: P840001
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional
• Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup,Followup,Followup
• Report Date: 10/25/2017

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: 02/28/2018
• Device Model Number: 97702
• Device Catalogue Number: 97702
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/08/2017
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 03/13/2017
• Initial Date FDA Received: 03/17/2017
• Supplement Dates Manufacturer Received: 08/29/2017; 08/29/2017; 10/02/2017; 10/16/2017
• Supplement Dates FDA Received: 08/29/2017; 09/06/2017; 10/05/2017; 10/25/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 09/06/2016
• 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