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

Model Number 97714

Device Problem Device Operates Differently Than Expected (2913)

Patient Problems Pain (1994); No Known Impact Or Consequence To Patient (2692)

Event Date 09/06/2016

Event Type  malfunction  

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

Information was received from a consumer regarding a patient who was implanted with a neurostimulator (ins) for peripheral neuropathy and spinal pain.It was reported that the patient¿s ins had shut off 4 or 5 times while she was charging.It was noted the patient¿s battery level was typically at 1/4 or more when she recharges.The patient was to contact her healthcare professional to run testing on the device.No symptoms were reported.Follow-up was conducted.

Event Description

Additional information was received from the patient.It was reported that the patient had not notified their doctor of the ins shutting off while charging.The patient reported that the ins had been turning off while charging due to user error.The patient reported that they accidentally pushed the off button on the charging unit.The patient mentioned that they had increased pain when the ins shut off during recharging.The patient reported that the issue was no longer occurring.No further complications are anticipated.

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.

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 woodward clark ; 7000 central avenue ne rcw215; minneapolis, MN 55432 ; 7635263920
• MDR Report Key: 6388991
• MDR Text Key: 69439572
• Report Number: 3004209178-2017-05252
• 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
• Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup,Followup
• Report Date: 05/18/2017

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?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 01/14/2015
• 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: 03/06/2017
• Initial Date FDA Received: 03/08/2017
• Supplement Dates Manufacturer Received: Not provided; Not provided; 04/24/2017
• Supplement Dates FDA Received: 05/10/2017; 05/18/2017; 10/02/2017
• Date Device Manufactured: 02/26/2014
• 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 Age: 52 YR
• Patient Weight: 49