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

Model Number 97714

Device Problems Unstable (1667); Battery Problem (2885); Charging Problem (2892); Communication or Transmission Problem (2896)

Patient Problems Complaint, Ill-Defined (2331); No Known Impact Or Consequence To Patient (2692)

Event Date 01/26/2016

Event Type  Injury  

Event Description

Information was received from a manufacturer's representative (rep) regarding a patient who was implanted with a neurostimulator for lumbar radiculopathy and spinal pain.It was reported there was poor recharge coupling; the patient never established more than 0-2 bars.An antenna locate did not resolve the issue.The antenna locate resulted in a 76, with a maximum of 4 bars.The implantable neurostimulator (ins) may have been tilted, but it was not too deep.It was further reported, the patient was able to consistently achieve 4 bars of coupling.The cause of the poor coupling was not determined and there were no diagnostics performed or planned related to the potentially tilted ins.Additional information received from a consumer via a rep reported there was poor coupling.The ins was possibly tilted in the pocket.It was noted the patient was very obese.Diagnostics/troubleshooting performed included impedance testing, which found all impedances to be within normal limits, an antenna locate feature was utilized, a reset was done on the original recharger, and a new recharger was attempted.Interventions/actions taken to resolve the issue included a new charger being sent to the patient after the appointment on (b)(6) 2016.After receiving the new recharger, the patient reported improved coupling.The rep met with the patient on (b)(6) 2016 and the patient was complaining of worsening coupling with 0-2 boxes.The rep was able to consistently achieve 4 boxes with the patient's charger.The patient's surgeon was made aware of the patient's complaint of worsening coupling and the patient had an appointment with the doctor on (b)(6) 2016.The issue was noted to have not resolved at the time of the report.Surgical intervention did not occur and it was unknown if surgical intervention was planned.

Manufacturer Narrative

(b)(4).

Manufacturer Narrative

Product analysis # (b)(4): c200/stim ins/battery/reduced capacity due to overdischarge the ins was received with no telemetry and no output from any electrode pair.Telemetry was restored after a short physician mode recharge.After telemetry was restored and a full normal recharge, the ins passed functional testing.According to the trace report taken from the ins, the last recharge while implanted took place on (b)(6) 2016 and the battery was charged to 3.675 volts.On (b)(6) 2016 the battery had depleted to the "lock" mode (<(><<)>(><(><<)><(><<)>)>3.575 volts).Subsequently, the battery depleted to an over discharged state prior to being received for analysis.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 healthcare provider indicating that the patient's ins was depleted at the time of their pocket revision surgery.The ins was replaced.The old ins was returned to the manufacturer.

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

Additional information received alleged that the ins failed well before the expiration of 9 years.

Manufacturer Narrative

(b)(4).

Event Description

It was also alleged that the patient suffered severe personal injuries as a result of the issue.

Manufacturer Narrative

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: diane wolf ; 7000 central avenue ne rcw215; minneapolis, MN 55432 ; 7635263987
• MDR Report Key: 5628320
• MDR Text Key: 44340150
• Report Number: 3004209178-2016-08751
• Device Sequence Number: 1
• Product Code: GZB
• Combination Product (y/n): N
• 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: 12/15/2016

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: 09/28/2016
• Device Model Number: 97714
• Device Catalogue Number: 97714
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/12/2016
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 04/29/2016
• Initial Date FDA Received: 05/03/2016
• Supplement Dates Manufacturer Received: Not provided; Not provided; Not provided; Not provided; 11/18/2016; 11/18/2016
• Supplement Dates FDA Received: 10/07/2016; 10/07/2016; 12/15/2016; 12/15/2016; 09/21/2017; 09/27/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 10/28/2015
• 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
• Patient Age: 61 YR