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

Model Number 97714

Device Problem Overheating of Device (1437)

Patient Problem Burning Sensation (2146)

Event Date 03/16/2017

Event Type  malfunction  

Manufacturer Narrative

The main component of the system and other applicable components are: product id: 977a260, serial# (b)(4), implanted: (b)(6) 2017, product type: lead.Product id: 977a260, serial# (b)(4), implanted: (b)(6) 2017, product type: lead.(b)(4) pertains to lead ((b)(4)) and lead ((b)(4)).(b)(4) pertains to lead ((b)(4)) and lead ((b)(4)).(b)(4) pertains to lead ((b)(4)) and lead ((b)(4)).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 patient who was implanted with an implantable neurostimulator (ins) for spinal pain via a manufacturer¿s representative (rep).The rep reported that the patients back heated up where the leads were when he slept.The rep reported that it woke the patient up every night about 5 hours into sleep.The rep reported that it didn¿t matter if stimulation was on or off.The patient reported that he sleeps on a (b)(6) mattress and wondered if it had anything to do with that.The rep reported that impedance was normal.The rep reported that no actions/interventions were performed because the system was working properly and the patient was getting pain relief.No further complications anticipated.

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: lisa clark ; 7000 central avenue ne rcw215; minneapolis, MN 55432 ; 7635263920
• MDR Report Key: 6416823
• MDR Text Key: 70425052
• Report Number: 3004209178-2017-05894
• Device Sequence Number: 1
• Product Code: GZB
• 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: 03/20/2017

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: 10/28/2017
• Device Model Number: 97714
• Device Catalogue Number: 97714
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 03/16/2017
• Initial Date FDA Received: 03/20/2017
• Supplement Dates Manufacturer Received: 03/16/2017
• Supplement Dates FDA Received: 10/02/2017
• Date Device Manufactured: 12/01/2016
• 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 Age: 77 YR