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

Model Number 97714

Device Problems Improper or Incorrect Procedure or Method (2017); Low Battery (2584); Device Displays Incorrect Message (2591); Device Operates Differently Than Expected (2913)

Patient Problems Stroke/CVA (1770); Seizures (2063); No Known Impact Or Consequence To Patient (2692)

Event Date 03/10/2017

Event Type  Injury  

Event Description

A patient reported via manufacturer representative a confirmed overdischarge event.The representative performed a 30 minute physician mode recharge (pmr) and then charged normally until he was able to clear the power on reset (por).The patient had a stroke or seizure on friday (b)(6) and a requested mri was unable to be performed due to the overdischarged battery.The representative cleared the por with 8840, but then the ins depleted below the charge level.No further complications were anticipated.The indication for implant was non-malignant pain.

Manufacturer Narrative

The event is no longer reportable for serious injury.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

Additional information was received from the representative (rep) and the consumer regarding the patient.It was reported that the patient did not charge her battery because she was in the hospital for an extended period of time.The rep performed a physician mode recharge and cleared the power on reset.As a result, the patient was able to recharge and gained stimulation.The rep reported that the seizure was due to medication she was on and not device related.No further complications were reported.

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 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 clark ; 7000 central avenue ne rcw215; minneapolis, MN 55432 ; 7635263920
• MDR Report Key: 6409310
• MDR Text Key: 70089401
• Report Number: 3004209178-2017-05714
• 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: company representative,consum
• Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date: 10/17/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/16/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 09/28/2016
• Device Model Number: 97714
• Device Catalogue Number: 97714
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 03/16/2017
• Date Device Manufactured: 11/04/2015
• 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 Age: 46 YR