MAUDE Adverse Event Report: MPRI SURESCAN; STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF

Model Number 977D260

Device Problem Malposition of Device (2616)

Patient Problem Loss of consciousness (2418)

Event Date 02/12/2016

Event Type  Injury  

Manufacturer Narrative

(b)(4).

Event Description

The manufacturer representative reported that the patient was in the middle of a trial and although everything tested fine they had to start over bringing the leads down based on the patient's responses.The second time the leads were in place the patient started experiencing slurred speech, his blood pressure was all over the map and he started becoming unresponsive.At one point during the trial the patient reported feeling nauseous.The healthcare professional (hcp) ended up taking out the leads, turning the patient on his back and calling 911 to go to the hospital.The hcp went with the patient and the patient was alert and doing fine and no trial leads were in place at this time.If additional information is received a follow-up report will be sent.

• Brand Name: SURESCAN
• Type of Device: STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF
• Manufacturer (Section D): MPRI; road 149 km 56.3; villalba PR 00766
• 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: 5492232
• MDR Text Key: 40062675
• Report Number: 2649622-2016-02790
• Device Sequence Number: 1
• Product Code: LGW
• 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: 02/12/2016

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: 11/03/2019
• Device Model Number: 977D260
• Device Catalogue Number: 977D260
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 02/12/2016
• Initial Date FDA Received: 03/10/2016
• Date Device Manufactured: 11/03/2015
• 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): Hospitalization; Other