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

Model Number 97712

Device Problems Failure to Deliver Energy (1211); Failure to Interrogate (1332); Improper or Incorrect Procedure or Method (2017); Low Battery (2584); Battery Problem (2885); Charging Problem (2892); Communication or Transmission Problem (2896); Device Operates Differently Than Expected (2913)

Patient Problem Therapeutic Effects, Unexpected (2099)

Event Date 03/02/2016

Event Type  Injury  

Manufacturer Narrative

Date of event was reported as (b)(6) 2016 (2 weeks after implant).

Event Description

Information received from the manufacturer¿s representative reported that there was a suspected overdischarge (od) on the patient¿s implantable neurostimulator (ins).The patient initially got great pain relief and then suddenly 2 weeks after implant they stopped feeling the stimulation and tried to charge but could not.The patient notified the representative but had difficulty meeting with them.The current representative met with the patient 3 weeks prior to report (probably (b)(6) 2016) where it was noted the patient was not able to charge.It was again noted that it was very difficult to meet with the patient and the current representative had tried 5 or 6 times before finally seeing the patient.Two physician recharge mode (prm) procedures were performed but the recharger did not flip to a normal charging session.It was noted that the patient did not seem proficient with the recharging process.The physician was notified of the device issue and the patient had an appointment with the physician to discuss replacing the ins.Follow up information received on june 15, 2016 from the manufacturer¿s representative reported that the cause of the issue was unknown.How ever, it was noted that the patient did not express knowledge of proper recharging of the device and that their story was ¿suspicious.¿ it was not believed the issue was rapid.The patient stated that they could not ¿connect¿ with the recharger and that ¿it would do nothing.¿ the difficult meeting with the patient was again mention (took 2 months to meet with the first representative, difficult to schedule to meet with the current representative).The representative was unable to stay for the hour but they tried 3 times to get the device starting to charge again.A replacement of the ins was scheduled for (b)(6) 2016 and it was planned to get the charging records from the recharger.The indication for use for the implanted device was noted as non-malignant pain and radicular pain syndrome (radiculopathies).If additional information is received, a follow up report will be submitted.

Event Description

Additional information received from the manufacturer's representative reported that the patient's ins was replaced due to the inability to recover the ins from the od state.Three prm procedures were attempted but was unable to pull the device out of the od.Recharging statistics did not provide an indication as to what happened.It was speculated that the ins battery may possibly be flipped.Follow up information received confirmed that the ins was replaced on (b)(6) 2016.It was noted that the recharging statistics (history) and it appeared the patient did not attempt proper charging.The patient insisted that they get another rechargeable ins battery model and education was re-enforced with them.The patient was pleased and satisfied with the therapy.The representative spoke with the patient the evening of replacement procedure and they were still unclear about proper recharging as apparent by their questions.Education was then re-enforced with the patient and was told to contact the representative immediately for any questions or issues.The patient was receptive and stated that "i never want to be without it again.".

Manufacturer Narrative

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 was received from the from the manufacturer representative (rep) as the device was returned and it indicated that the charge would not hold, depleted early.The patient recovered without sequela after the device was removed.

Manufacturer Narrative

Analysis of the ins (serial # (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.

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: 5738940
• MDR Text Key: 47851433
• Report Number: 3004209178-2016-12618
• 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: company representative,consum
• Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup,Followup,Followup
• Report Date: 10/26/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/21/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 05/28/2016
• Device Model Number: 97712
• Device Catalogue Number: 97712
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/12/2016
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 09/30/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 07/11/2015
• 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: 44 YR