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

Model Number 97714

Device Problem Delayed Charge Time (2586)

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

Event Date 07/08/2014

Event Type  Injury  

Event Description

It was reported the patient has only been able to get 2 coupling boxes on the implantable neurostimulator recharger (insr) screen to show black since implant.He could only get to a 25% charge after 3 hours.A request was made to have a replacement recharger sent to the patient.It was noted the event was unresolved at the time of the report.The patient was not getting good coupling.The anomaly appeared to have occurred through product use.There was no indication of patient harm.Upon device return, analysis was unable to confirm the complaint.No issues were found during bench testing, no issues with charging implantable neurostimulator (ins) or recharger, or communications.Additional information received reported the patient is still experiencing coupling problems and they are discussing with their health care provider (hcp) for what steps will be taken to resolve the problem.No cause of the event had been determined and despite being sent a new charging unit the issue was not resolved.The patient had an appointment scheduled with their health care provider (hcp) for (b)(6) 2014.A week later it was reported that a battery replacement was being scheduled for a future date.Since implant the patient could only get two bars shaded so his implantable neurostimulator (ins) never fully recharges and sometimes the recharger has turned off.If additional information is received, a follow up report will be sent.

Event Description

It was later reported that the patient could not get his ins to fully charge.A coupling problem was reported; the patient still could not get more than two black squares when charging.Replacing the charging unit did not solve the issue.The patient will have the recharger charging the ins, and it randomly will shut off without any notice.The screen stays blank.This happened with both the old recharger and newer one received.When the antenna slips away from the ins site, the recharger generally lets him know.The patient thought this was an issue with the ins.When the patient charges, he wears a belt and has tried different positions.Propping a pillow behind him was also tried.The patient could feel the implant and it feels like its flat.The hcp implanted the ins in the center of the patient¿s back which was right where his injury is; he did not understand this since most of the videos he has seen the implant was on the right or left side.

Event Description

It was additionally reported that the patient attempted to charge 61 times based on the 8840 stats without being able to get good coupling.Charging issues were noted.

Event Description

Additional information received reported that the patient had an x-ray to verify if their battery was flipped.The x-ray showed the leads coming off the left side of the implantable neurostimulator (ins).It appeared that the ins was flipped.A new antenna and different rechargers had been tried but they were unable to get more than 2 coupling bars.The patient¿s battery was discharged at the time of the x-ray but they were able to get 2 coupling bars.A pocket revision was going to be scheduled.

Manufacturer Narrative

Concomitant medical products: product id: 977a260, serial# (b)(4), product type: lead.Product id: 977a260, serial# (b)(4), product type: lead.Product id: 97740, serial# (b)(4), product type programmer, patient.Product id: neu_recharger_acc, product type: recharger.Product id: 37751, serial# (b)(4), product type: recharger.(b)(4).

Manufacturer Narrative

(b)(4).

Event Description

Additional information received reported that the patient¿s coupling problem has persisted and they are now unable to get any coupling bars which has resulted in them not being able to use the stimulation.They are able to feel the device and it is ¿pretty flat and up against the skin.¿ they have tried replacing the recharger belt but it did not work and had a ct scan performed 4-6 weeks prior to the call.They noted that all the evidence is leading to a problem with the implantable neurostimulator (ins) and they would need it replaced.

Event Description

Additional information received reported that the patient still had concerns with their device or therapy and their concerns were not resolved.The patient was still having problems.

Manufacturer Narrative

(b)(4).

Event Description

A manufacturer's representative reported that the consumer had their implantable neurostimulator replaced.The implantable neurostimulator experienced premature battery depletion as well as several overdischarges.The manufacturer's representative was unable to jump start the implantable neurostimulator after the third attempt to "trickle charge".It was also confirmed that the implantable neurostimulator was flipped within the patient.Should additional information be received, a follow up report will be sent out.

Manufacturer Narrative

Concomitant products: product id: 977a260, serial# (b)(4), implanted: (b)(6) 2014.Product type: lead.Product id: 977a260, serial# (b)(4), implanted: (b)(6) 2014, product type: lead.Product id: 97740, serial# (b)(4), product type: programmer, patient.Product id: neu_recharger_acc, product type: recharger.Product id: 37751, serial# (b)(4), product type: recharger.Analysis results were not available at the time of this report.A follow-up report will be sent when analysis is completed.

Event Description

Additional information received reported that the patient had difficulty charging, which lead to an overdischarged battery.The battery was flipped.The patient recovered without sequela.

Manufacturer Narrative

Analysis of the implantable neurostimulator (serial number (b)(4)) found that the battery had reduced capacity due to overdischarge.

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 NEUROMODULATION; 7000 central avenue ne rcw215; minneapolis MN 55432
• Manufacturer Contact: diane wolf ; 7000 central avenue ne rcw215; minneapolis, MN 55432 ; 7635263987
• MDR Report Key: 4261487
• MDR Text Key: 5046072
• Report Number: 3004209178-2014-21849
• Device Sequence Number: 1
• Product Code: GZB
• 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,Company Representative,company representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup,Followup,Followup
• Report Date: 09/03/2015

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: 04/28/2015
• Device Model Number: 97714
• Device Catalogue Number: 97714
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/01/2015
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 05/22/2015
• Initial Date FDA Received: 11/19/2014
• Supplement Dates Manufacturer Received: Not provided; Not provided; Not provided; Not provided; Not provided; Not provided; 11/02/2015
• Supplement Dates FDA Received: 12/18/2014; 01/08/2015; 03/24/2015; 05/20/2015; 06/10/2015; 11/24/2015; 09/19/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 06/03/2014
• 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): Required Intervention
• Patient Age: 00071 YR