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

Model Number 97702

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

Patient Problems Stroke/CVA (1770); Death (1802); Hemorrhage/Bleeding (1888)

Event Date 10/11/2014

Event Type  Death  

Event Description

The patient had a stroke during and post-op, and died in the hospital the next day.This was a massive hemorrhagic event with midline shift.The family decided to withdraw support.The product had no relevance related to the event.There was no alleged product issue.No diagnostic testing or troubleshooting was performed.Additional information has been requested to find out more information regarding this event.If additional information is received, a follow up will be sent.

Manufacturer Narrative

Concomitant medical products: product id: 97740, serial# (b)(4), product type: programmer, patient.Product id: 977a260, serial# (b)(4), implanted: (b)(6) 2014, product type: lead.Product id: 977a260, serial# (b)(4), implanted: (b)(6) 2014, product type: lead.(b)(4).

• 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 NEUROMODULATION; 7000 central avenue ne rcw215; minneapolis MN 55432
• Manufacturer Contact: diane wolf ; 7000 central avenue ne rcw215; minneapolis, MN 55432 ; 7635263987
• MDR Report Key: 4224147
• MDR Text Key: 5063949
• Report Number: 3004209178-2014-20905
• Device Sequence Number: 1
• Product Code: GZB
• 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
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 10/13/2014

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: 11/28/2015
• Device Model Number: 97702
• Device Catalogue Number: 97702
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 10/13/2014
• Initial Date FDA Received: 11/04/2014
• Date Device Manufactured: 06/07/2014
• 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: 00069 YR