MAUDE Adverse Event Report: MEDTRONIC PUERTO RICO OPERATIONS CO. RESTORE SENSOR; STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF

Model Number 37714

Device Problems Intermittent Continuity (1121); High impedance (1291); Inappropriate/Inadequate Shock/Stimulation (1574); Battery Problem (2885); Electromagnetic Compatibility Problem (2927)

Patient Problems Electrocution (1827); Loss of consciousness (2418)

Event Date 07/28/2016

Event Type  Injury  

Event Description

Information was received via a manufacturer representative from a patient who was implanted with a neurostimulator for spinal pain.It was reported that the patient was electrocuted and after being electrocuted, the implantable neurostimulator has been turning off/on and no longer holds a charge.The impedance test showed leads were intact.The implantable neurostimulator was scheduled to be replaced on (b)(6) 2016.

Manufacturer Narrative

(b)(4).

Event Description

Additional information was received from the manufacturer representative that reported that the electrocution was caused by a faulty lamp, and not the patient's neurostimulator.The electrocution knocked her unconscious and she was evaluated in the emergency room and the only sustained injury was to her implantable neurostimulator.

Manufacturer Narrative

(b)(4).

Event Description

Additional information was received indicating that the patient's device was replaced, and the ins was returned to analysis.It was stated that the after the patient was accidentally electrocuted, their ins stopped working properly, and the patient received a significant jolt after turning the device back on.It was noted that the patient would only receive stimulation if their head was cocked backwards, and the device was also zapping them.It was also reported that there were high impedances in electrode 15.

Manufacturer Narrative

Analysis of the implantable neurostimulator did not find any significant anomalies.Evaluation conclusion code does not apply.Evaluation result code does not apply.

Manufacturer Narrative

If information is provided in the future, a supplemental report will be issued.

• Brand Name: RESTORE SENSOR
• Type of Device: STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR 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: diane wolf ; 7000 central avenue ne rcw215; minneapolis, MN 55432 ; 7635263987
• MDR Report Key: 5912248
• MDR Text Key: 53436441
• Report Number: 3004209178-2016-17810
• 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,consum
• Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup,Followup,Followup
• Report Date: 12/08/2016

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: 09/28/2015
• Device Model Number: 37714
• Device Catalogue Number: 37714
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/06/2016
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 08/03/2016
• Initial Date FDA Received: 08/29/2016
• Supplement Dates Manufacturer Received: Not provided; Not provided; Not provided; 12/07/2016
• Supplement Dates FDA Received: 08/30/2016; 09/26/2016; 12/08/2016; 09/25/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 11/10/2014
• 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): Other; Required Intervention
• Patient Age: 51 YR