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

Model Number 97702

Device Problems Migration or Expulsion of Device (1395); Overheating of Device (1437)

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

Event Date 04/12/2018

Event Type  malfunction  

Manufacturer Narrative

Information references the main component of the system.Other relevant device(s) are: product id: 977a260, serial/lot #: (b)(4), udi#: (b)(4); product id: 977a260, serial/lot #: (b)(4), udi#: (b)(4).If information is provided in the future, a supplemental report will be issued.

Event Description

Information was received from a consumer via a manufacture representative regarding a patient implanted with an implantable neurostimulator (ins).It was reported that the patient had a blister and was feeling a burning sensation around the battery site following an appointment on (b)(6) 2018 in which the amplitude was increased from 1 to 2 ma.It was also noted that the patient programmer was not communicating with the ins but this resolved after the rep replaced the batteries.Additional information received from the rep reported that the patient developed a 'burn' after programming on the left side of their mid-thoracic area about 2.5 in length.The patient showed a picture of a dark pencil eraser sized lesion from (b)(6).This issue was all healed at the time of the call with no residual skin sensitivity.The patient's hcp initially thought this skin issue was shingles, but the patient did not believe so.It was also reported that the x-ray showed that the leads had migrated.The patient denied any falls but stated that they had pneumonia in (b)(6) and coughed for 3 straight weeks.The x-rays showed that the leads retracted to the t-9 vertebrae.New electrode configurations were programmed to attempt to improved pain control.Follow-up was conducted.No further complications were reported.

Manufacturer Narrative

Information references the main component of the system and other applicable components are: product id (b)(4) lot# serial# (b)(4) implanted: explanted: product type lead product id (b)(4) lot# serial# (b)(4) implanted: explanted: product type lead.If information is provided in the future, a supplemental report will be issued.

Event Description

Additional information received from the representative.It was reported that the cause of the burning sensation at the battery site, blistering and lesion was not determined.After further evaluation of the patient the physician didn't think it was device related.Some new programming was performed to resolve the issues and the pw was reduced to 450 and the rate was reduced to 60 to help resolve the lead migration issue.The patient reported that the stimulation coverage felt better.This information was confirmed with the physician/account.No further complications reported.

• 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: 7432921
• MDR Text Key: 105764858
• Report Number: 3004209178-2018-08108
• Device Sequence Number: 1
• Product Code: LGW
• UDI-Device Identifier: 00643169109513
• UDI-Public: 00643169109513
• 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: 05/09/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/16/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 12/14/2018
• Device Model Number: 97702
• Device Catalogue Number: 97702
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 04/20/2018
• Date Device Manufactured: 06/19/2017
• 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 Age: 75 YR