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

Model Number 97714

Device Problems Failure to Deliver Energy (1211); Electro-Static Discharge (2149)

Patient Problem Therapeutic Effects, Unexpected (2099)

Event Type  Injury  

Event Description

Additional information received reported that the manufacturer¿s representative was not aware of the patient¿s battery being discharged by lightning strikes and there was no record of a manufacturer¿s representative clearing a por (power on reset) or needing to intervene with the patient¿s discharges.It was stated that it ¿appeared that she was able to recharge on her own.¿ it was stated that x-rays were performed (b)(6) 2014 and they did not show lead fracture, lead migration, disconnection from the header block of the implantable pulse generator (ipg), or any other indication of what might be causing high impedance.It was stated that the patient was scheduled to see the implanting healthcare professional (hcp) (b)(6) 2014 to discuss options.It was stated that the issue was unresolved at the time of this report and the patient was not receiving effective therapy.It was noted that the patient didn¿t show for the appointment.It was later reported that the patient had loss of therapeutic effect since july following a car accident and some falls around the same time frame.It was stated that the patient had no stimulation sensation.It was reported that electrode 1 read >20000 ohms.It was stated that the manufacturer¿s representative tried various programming options (up and down the lead, up to 10v with no stimulation sensation.It was noted that when stimulation was turned off or down to 0.0v, the patient reported feeling a ¿release of pressure.¿ it was stated #1 was not used in programming.It was confirmed that the lead was still located in t11.It was stated that recharging the battery was working ¿just fine.¿ it was reported that the patient charged on (b)(6) 2014 per the 8840 (clinician programmer) statistics.It was stated that revision surgery was being planned for in a couple weeks once insurance approval was given.

Event Description

It was reported that the patient met with a company representative for reprogramming.Impedance testing was done and all were normal except electrode #1 was greater than 10,000 ohms.When asked for additional details about what happened to the product relevant to this event, it was stated that the patient had a history of 2 falls since implant.In addition, the patient stated that ¿during lightning strikes her stimulator had discharged on 2 occasions.¿ the patient¿s status was alive with no injury.It was further reported that the patient did not feel stimulation, even at max output.The patient had less than 50% therapy relief, and it was stated that she was not getting therapy at this point.Impedances ranged from 1,753 ohms to 10,000 ohms.Many other impedances were up to 4,000 ohms.Xrays had been ordered but not yet completed (as of (b)(6) 2014).Reprogramming had been done.The patients status remained alive with no injury.It was stated that a revision may be needed.Additional information was requested, if received a follow up report will be sent.

Manufacturer Narrative

Concomitant medical products: product id 97754, serial# (b)(4), product type: recharger; product id 97740, serial# (b)(4), product type: programmer, patient; 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.(b)(4).

Manufacturer Narrative

(b)(4).

Event Description

It was further reported that the patient did undergo revision on (b)(6) 2014.The patient was doing well; she had appropriate stimulation again, and a working system.

Manufacturer Narrative

Final analysis of the stimulator revealed no significant anomaly.Final analysis of the lead (serial (b)(4) revealed that conductors were broken at the distal end of the lead (2.1 cm from the end).Final analysis of the second lead (serial (b)(4) revealed no anomalies.Final analysis of the injex anchor revealed no significant anomaly.

Manufacturer Narrative

(b)(4).Conclusion code no longer applies to the event.

Event Description

Additional information received reported the patient's battery drained "like 50% down in minutes" after lightning.The patient "got a shock after the lightning" and it was painful.The patient "closes her eyes." the patient noticed this 6 months ago.When it was raining/lightning around the patient, the ins felt like it was shocking her and the ins was depleting at a faster rate.The patient reportedly verified this with her programmer that the ins drained.The patient had a follow up appointment on (b)(6) 2015.No outcome was reported regarding this event.Further follow-up is being conducted to obtain this information.If additional follow-up is received, a follow-up report will be sent.

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 MED REL MEDTRONIC PUERTO RICO; ceiba norte industrial park, r; 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: 4042540
• MDR Text Key: 4830018
• Report Number: 3004209178-2014-16021
• 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: 08/04/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/27/2014
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 09/14/2014
• Device Model Number: 97714
• Device Catalogue Number: 97714
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/06/2014
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 12/31/2014
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 10/21/2013
• 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: 00038 YR