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

Model Number 97712

Device Problems Energy Output To Patient Tissue Incorrect (1209); Electromagnetic Compatibility Problem (2927)

Patient Problem Therapeutic Effects, Unexpected (2099)

Event Date 03/25/2018

Event Type  malfunction  

Manufacturer Narrative

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

Event Description

Information was received from a patient via manufacturer representative.It was noted that the patient¿s implantable neurostimulator (ins) battery came on by itself during the night.No environmental or external factors were reported that may have led or contributed to the issue.The manufacturer representative stated that they hadn't seen the patient yet, but that the patient would be seen at their physician¿s office on (b)(6) 2018.It was noted that the issue was not been resolved.No further complications were reported or anticipated.The patient¿s status at the time of this report is ¿alive, no injury.¿ indication for use is spinal pain.

Manufacturer Narrative

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

Event Description

Additional information was reported that the patient was seen at her physician's office on (b)(6) 2018.Her system was off when first interrogated.All impedances were within normal limits.Her programmer and recharger were functioning fine.A re-reeducation on the units was needed.A reprogramming was performed to her satisfaction.The patient stated that when her ins turns itself on, the television screen also became "staticky".The patient denies any form of emi nearby.It is unknown if the ins turning it's self on by itself has been resolved.This was confirmed with the physician.No further information was 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: 7379704
• MDR Text Key: 103820054
• Report Number: 3004209178-2018-05960
• Device Sequence Number: 1
• Product Code: LGW
• 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
• Report Date: 04/19/2018

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: 03/14/2017
• Device Model Number: 97712
• Device Catalogue Number: 97712
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 03/26/2018
• Initial Date FDA Received: 03/28/2018
• Supplement Dates Manufacturer Received: 03/29/2018
• Supplement Dates FDA Received: 04/19/2018
• Date Device Manufactured: 04/19/2016
• 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: 71 YR