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

Model Number 97714

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Death (1802); Overdose (1988)

Event Date 01/25/2014

Event Type  Death  

Manufacturer Narrative

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

A consumer reported the patient passed away ¿only three days after the implant surgery,¿ but it was later confirmed the patient died on (b)(6) 2014.It was noted the patient didn¿t die in a medical facility, hospice, or care facility.The consumer stated they thought the reason the patient passed away was related to the stimulator and the surgery, but according to the autopsy the patient passed away due to medications they had been taking.According to the consumer they believe the patient ¿wasn¿t instructed on how to take the medications,¿ so they took ¿both¿ medications together.Relevant medical history includes spinal pain.

Event Description

Additional information received from the healthcare provider (hcp) reported they last saw the patient in their office on (b)(6) 2013.The patient underwent implant with the neurosurgeon after this.

Event Description

Additional information received from the healthcare provider (hcp) reported they were unaware of the patient¿s death until (b)(6) 2016 when another doctor called them to inform them the patient died.They were told by the doctor the cause of death was medication overdose.The hcp had no other information regarding the patient, death, or if any reports would be requested about the death.

Manufacturer Narrative

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 MED REL MEDTRONIC PUERTO RICO; road 31, km. 24, hm 4; ceiba norte industrial park; juncos PR 00777
• Manufacturer (Section G): MEDTRONIC MED REL MEDTRONIC PUERTO RICO; 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: 6192653
• MDR Text Key: 62914914
• Report Number: 3004209178-2016-26922
• 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: consumer,health professional
• Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup,Followup
• Report Date: 02/02/2017

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?: No
• Device Operator: Health Professional
• Device Expiration Date: 10/28/2014
• 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: 12/19/2016
• Initial Date FDA Received: 12/21/2016
• Supplement Dates Manufacturer Received: Not provided; Not provided; 02/01/2017
• Supplement Dates FDA Received: 12/22/2016; 02/02/2017; 09/28/2017
• Date Device Manufactured: 12/04/2013
• 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): Death
• Patient Age: 33 YR