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

Model Number 97702

Device Problems Premature Discharge of Battery (1057); Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 04/11/2016

Event Type  Injury  

Event Description

Both the patient and healthcare professional (hcp) reported through a manufacturer representative that the patient¿s implantable neurostimulator (ins) had reached end of service (eos) on (b)(6) 2016.It was stated the ins experienced premature battery depletion.It was noted the patient ¿had never had a connection issue and was extremely satisfied by the clinical outcome.¿ it was further noted the patient had utilized one stimulation group, which was set to continuous stimulation.Impedance testing was performed and found impedances were in the range of ¿700-900 ohms.¿ the cause of the premature depletion was unknown.Replacement of the ins was planned in the future as a result of the event, though it was unknown whether the replacement had been scheduled yet at the time of report.The issue remained unresolved at the time of report and the patient was alive with no injury at that time.

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

Additional information received indicated the product was received by the company at an international site, and was shipped to a different site for analysis; however the product has not been received at the site to perform analysis.The current device location is unknown and an investigation is ongoing to locate the device.

Manufacturer Narrative

(b)(4) has been removed.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

Device analysis for ins (b)(4) revealed no significant anomaly.The ins battery was at normal end of life.Telemetry and output was okay.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 clark ; 7000 central avenue ne rcw215; minneapolis, MN 55432 ; 7635263920
• MDR Report Key: 5641543
• MDR Text Key: 44776772
• Report Number: 3004209178-2016-09134
• Device Sequence Number: 1
• Product Code: GZB
• Combination Product (y/n): N
• Reporter Country Code: IT
• 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: 03/01/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/09/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 08/28/2016
• Device Model Number: 97702
• Device Catalogue Number: 97702
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/17/2016
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 03/01/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/06/2015
• 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): Required Intervention