MEDTRONIC NEUROMODULATION IMPLANTABLE DRUG INFUSION PUMP PUMP, INFUSION, IMPLANTED, PROGRAMMABLE
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Model Number NEU_UNKNOWN_PUMP |
Device Problems
Difficult to Advance (2920); Material Integrity Problem (2978)
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Patient Problem
Device Embedded In Tissue or Plaque (3165)
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Event Date 10/11/2021 |
Event Type
Injury
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Manufacturer Narrative
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Other relevant device(s) are: product id: 8781, serial/lot #: (b)(4), ubd: 14-may-2023, udi#: (b)(4), product type: catheter; product id: 8781, serial/lot #: (b)(4), ubd: 28-jun-2023, udi#: (b)(4), product type: catheter.
If information is provided in the future, a supplemental report will be issued.
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Event Description
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Information was received from foreign healthcare provider (hcp) via a manufacturer's representative (rep) regarding a patient with an implantable pump.
On (b)(6) 2021, it was reported that the patient was having a catheter implanted.
It was noted that, because the patient had a lumbar kyphosis, the placement of the catheter was difficult.
While trying to manipulate the catheter to advance it along the spinal column, the hcp reported that the catheter broke 1 cm from the extremity of the catheter.
The hcp attempted to implant a second catheter but the catheter broke at the same level.
In the end, no catheter was implanted, but 2 pieces of catheter (1 cm each) were left in the spinal canal.
The patient reportedly would not receive any tdd therapy.
The issue was considered resolved.
The patient's status was listed as "alive - no injury".
Additional information was received from a foreign manufacturer's representative (rep) on 2021-oct-20.
It was reported that no pump or catheter were implanted in the patient as the event happened during surgery.
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