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

Model Number	97714
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Paralysis (1997); Thrombosis (2100); Vomiting (2144); Ambulation or Postural Difficulties (2544)
Date of Event	08/24/2017
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Information references the main component of the system and other applicable components are: product id: 97714, serial# (b)(4), implanted: (b)(6) 2017, product type: implantable neurostimulator.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 or Problem Description
Information was received from a healthcare provider (hcp) via a manufacturer's representative (rep) regarding an implantable neurostimulator (ins) for the treatment of non-malignant pain.It was reported that the patient had a loss of feeling in both legs post operation.The patient was profusely vomiting post operation.The healthcare provider (hcp) was called following the following morning and upon exam noticed the patient was unable to move their legs.An mri was ordered and the lead and battery were removed due to the mri showing a blood clot underneath the lead.No further complications were reported or anticipated.No device allegations were made.
Additional Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.
Event or Problem Description
Additional information was received from a manufacturer's representative (rep).The rep reported that the cause of the blood clot was not determined.
Additional Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.
Event or Problem Description
Additional information was received from healthcare professional (hcp) via a manufacturer representative (rep).It was reported that the hcp was meeting with the patient for the 2nd time and the patient reported that following the implant of their system, they became paralyzed and the lead was removed that night of implant.The rep was seeking information regarding an mri as the hcp wanted to do an mri of the thoracic spine.The rep said the current plan was being discussed and the hcp was to get some x-rays; it was also discussed to have the ins removed so they could get an mri, x-rays and do a possible intrathecal baclofen trial.No further complications were reported.

• Brand Name: SURESCAN
• Common Device Name: 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
• MDR Report Key: 6850795
• Report Number: 2649622-2017-10161
• Device Sequence Number: 41118
• Product Code: LGW
• UDI-Device Identifier: 00643169464599
• UDI-Public: 00643169464599
• Combination Product (Y/N): N
• Initial Reporter State: NY
• Initial Reporter Country: US
• PMA/510(K) Number: P840001
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2017
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 09/26/2018

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?: No
• Operator of Device: Health Professional
• Device Expiration Date: 06/14/2018
• Device Model Number: 97714
• Device Catalogue Number: 97714
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/05/2017
• Supplement Date Received by Manufacturer: 09/07/2017; 09/24/2018
• Initial Report FDA Received Date: 09/07/2017
• Supplement Report FDA Received Date: 09/20/2017; 09/26/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 54 YR